AngioSculpt PTCA RX Scoring Balloon CatheterRecalls & reported problems across all models

We found 8 models of AngioSculpt PTCA RX Scoring Balloon Catheter by Spectranetics Corporation in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2018 and Aug 23, 2023 — classified as 2 deaths, 13 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (25 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported AngioSculpt PTCA RX Scoring Balloon Catheter problems

AngioSculpt PTCA RX Scoring Balloon Catheter models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AngioSculpt PTCA RX Scoring Balloon Catheter 2200-3010

  Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
  2 deaths14 reports
• AngioSculpt PTCA RX Scoring Balloon Catheter 2200-2510

  Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
  10 reports
• AngioSculpt PTCA RX Scoring Balloon Catheter 2200-3510

  Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
  9 reports
• AngioSculpt PTCA RX Scoring Balloon Catheter 2200-3015

  Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
  6 reports
• AngioSculpt PTCA RX Scoring Balloon Catheter 2200-2515

  Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
  5 reports
• AngioSculpt PTCA RX Scoring Balloon Catheter 2200-3515

  Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
  5 reports
• AngioSculpt PTCA RX Scoring Balloon Catheter 2200-2010

  Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
  4 reports
• AngioSculpt PTCA RX Scoring Balloon Catheter 2200-2015

  Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
  2 reports

Recent AngioSculpt PTCA RX Scoring Balloon Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2023Material Rupture; Material Rupture

  BASED ON THE DEVICE EVALUATION, A SEMI BALLOON RADIAL TEAR WAS OBSERVED. THIS PRODUCT PROBLEM IS BEING REPORTED DUE TO THE SEMI BALLOON RADIAL TEAR; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17605213 ↗
• MalfunctionJun 14, 2023Material Rupture; Material Rupture

  INITIAL MDR REPORTED A BALLOON RUPTURE BELOW RBP. HOWEVER, BASED ON THE OBSERVATIONS FROM THE RETURNED PRODUCT ANALYSIS, NO BALLOON RUPTURE WAS OBSERVED AS DESCRIBED IN THE COMPLAINT DETAILS. THEREFORE, THIS EVENT IS NO LONGER REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17130891 ↗
• MalfunctionJun 7, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID RCA. DURING INFLATION AT 14 ATM, THE BALLOON RUPTURED AND A KINK WAS OBSERVED NEAR THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17080989 ↗
• MalfunctionMar 27, 2023Deflation Problem; Deflation Problem

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID LAD. DURING THE 3RD INFLATION AT 18 ATM (RBP), CONTRAST LEAKED FROM THE GUIDEWIRE EXIT PORT. AN ATTEMPT WAS MADE TO DEFLATE THE BALLOON, BUT UNABLE TO REMOVE THE CONTRAST. THE DEVICE WAS PULLED THROUGH THE GUIDE CATHETER, BUT COULD NOT BE RETRIEVED DUE TO RESISTANCE. SEVERAL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON, BUT ONLY ABLE TO DEFLATE A LITTLE BIT. WITH FORCE APPLIED, THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED DUE TO THE BALLOON UNABLE TO FULLY DEFLATE. THERE IS A POTENTIAL FOR HARM WITH RECURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16623844 ↗
• MalfunctionJan 11, 2023Sharp Edges; Sharp Edges

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RCA. THERE WERE NO ISSUES DURING INSERTION; HOWEVER, AFTER THE 1ST INFLATION AND DEFLATION, THE WIRE WAS FLIMSY. THE PHYSICIAN REMOVED THE DEVICE AND A KINKED SHAFT WITH A SHARP EDGE WAS OBSERVED. A NEW ANGIOSCULPT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED DUE TO A SHARP EDGE OBSERVED. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142170 ↗
• MalfunctionJan 4, 2023Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT THE MID LAD ARTERY. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT AN UNKNOWN PRESSURE. THE PROCEDURE WAS COMPLETED WITH A NEW ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE IT IS UNKNOWN IF THE BALLOON RUPTURED ABOVE THE RATED BURST PRESSURE (RBP). THERE IS POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16097613 ↗
• InjuryNov 16, 2022Material Separation; Material Separation

  THE ANGIOSCULPT CORONARY DEVICE WAS USED OFF-LABEL IN A PERIPHERAL PROCEDURE TO TREAT A CALCIFIED AND TORTUOUS DISTAL AT. UPON REMOVAL, RESISTANCE WAS NOTED AND THE DEVICE SEPARATED AT THE DISTAL SHAFT. ALL PARTS WERE RETRIEVED USING A NON-PHILIPS BALLOON INFLATED TO LOW PRESSURE AND PULLED BACK INTO THE SHEATH. ANGIOGRAM AND FLUOROSCOPY CONFIRMED NO DEVICE FRAGMENT WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SUSPECT DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PHYSICIAN THOUGHT THAT THE TORTUOUS ANGLE CAUSED THE SHAFT ISSUE AND RESISTANCE. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE SHAFT SEPARATION REQUIRING MEDICAL INTERVENTION FOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15810783 ↗
• MalfunctionOct 12, 2022Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED FOR PRE-DILATION ON A CALCIFIED MID LAD. AFTER ADVANCING THE ANGIOSCULPT TO THE LESION, THE BALLOON WAS INFLATED TO NOMINAL PRESSURE (8 ATM) BUT DID NOT INFLATE AS EXPECTED UNDER FLUOROSCOPY. UPON REMOVAL OF THE ANGIOSCULPT, A BALLOON RUPTURE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592232 ↗
• MalfunctionAug 12, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID LAD. DURING INFLATION AT 16 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15220875 ↗
• InjuryJul 18, 2022Deflation Problem; Entrapment of Device; Deflation Problem; Entrapment of Device

  THE ANGIOSCULPT CATHETER WAS USED IN THE CORONARY ARTERY TO TREAT THE LAD AND DIAGONAL BRANCH. THE CATHETER WAS ADVANCED OVER A NON-MANUFACTURER¿S GUIDE WIRE WITH NO ISSUES REPORTED. POST ANGIOPLASTY, THE CATHETER BECAME ENTANGLED WITH THE GUIDE WIRE; THEREFORE, WAS REMOVED AS A UNIT. UPON REMOVAL, THE BALLOON APPEARED TO BE HALF-DEPLOYED AND DID NOT REWRAP FULLY TO ITS ORIGINAL POSITION, WHICH LIKELY CAUSED THE ENTANGLEMENT. THE LESION WAS REWIRED AND COMPLETED THE PROCEDURE WITH A NON-ANGIOSCULPT BALLOON. NO PATIENT INJURY REPORTED. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING REPORTED DUE TO THE BALLOON UNABLE TO FULLY DEFLATE AND PLACEMENT OF A NEW GUIDEWIRE WAS NECESSARY TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047013 ↗
• InjuryJul 14, 2022Material Rupture; Material Separation; Material Rupture; Material Separation

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED PROXIMAL RCA. PRIOR TO THE ANGIOSCULPT, A ROTABLATION DEVICE WAS USED. THE ANGIOSCULPT WAS INFLATED MULTIPLE TIMES AND DURING THE 4TH INFLATION AT 16 ATM FOR 12 SECONDS, THE BALLOON BURST. UPON REMOVAL, THE DEVICE WAS CAUGHT IN THE PATIENT¿S ANATOMY AND UNABLE TO BE REMOVED. WITH MUCH FORCE APPLIED, A PORTION OF THE BALLOON SEPARATED RADIALLY IN THE PATIENT. THE PATIENT WAS IN STABLE CONDITION, BUT WAS TRANSFERRED BY HELICOPTER TO ANOTHER HOSPITAL FOR BYPASS. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE BALLOON RUPTURED RADIALLY AND REQUIRED SURGICAL INTERVENTION (BYPASS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15020128 ↗
• MalfunctionJul 11, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED PROXIMAL LAD. DURING INFLATION AT 18 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED AT RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983093 ↗
• MalfunctionJul 11, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED MID LAD. DURING INFLATION AT 17 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983068 ↗
• MalfunctionJun 29, 2022Material Rupture; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED IN A SEVERELY CALCIFIED MID LAD. DURING INFLATION AT 18 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A NON-ANGIOSCULPT DEVICE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14861827 ↗
• MalfunctionApr 26, 2022Peeled/Delaminated; Material Rupture; Peeled/Delaminated; Material Rupture

  THE ANGIOSCULPT DEVICE WAS USED TO TREAT A SEVERELY CALCIFIED MID LAD. DURING INFLATION AT 16 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURY REPORTED. DURING THE DEVICE EVALUATION, THE BALLOON RUPTURE WAS CONFIRMED AND A DISTAL BOND PEEL WAS OBSERVED. THIS PRODUCT PROBLEM IS BEING SUBMITTED CONSERVATIVELY BECAUSE THE BALLOON RUPTURED BELOW RBP AND THE DISTAL BOND PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14213657 ↗

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