Cook G09500Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002095007), received between Apr 18, 2017 and Jun 30, 2022 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A BILE DUCT DRAINAGE PROCEDURE AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER SEPARATED AT THE HUB WHEN THE USER WAS FIXING THE CATHETER TO THE PATIENT'S SKIN. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877048 ↗
• MalfunctionMay 5, 2020Material Separation; Material Separation

  AS REPORTED, A (B)(6) YEAR-OLD MALE PATIENT REQUIRED PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER DURING A BILIARY DRAINAGE EXCHANGE PROCEDURE. WHILE PREPARING THE DRAIN FOR PLACEMENT, THE OPERATOR REPORTED THE HUB CAME OFF WHEN INSERTING THE PLASTIC STIFFENER. THE CATHETER DID NOT MAKE PATIENT CONTACT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10026484 ↗
• InjurySep 6, 2018Material Separation; Material Separation

  IT WAS REPORTED AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS PLACED INTO THE TRANSPLANTED KIDNEY AND BLADDER OF A PATIENT DURING A NEPHROURETERAL DRAINAGE PROCEDURE. HUB SEPARATION FROM THE CATHETER WAS REPORTED TO HAVE HAPPENED TWO TIMES, ONE WEEK APART. IN THE SECOND OCCURRENCE, IT WAS FOUND POST PROCEDURE THAT THE CATHETER HAD SEPARATED FROM THE HUB. THE DEFECTIVE CATHETER WAS REMOVED AND REPLACED WITH A LIKE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE FIRST OCCURRENCE IS DETAILED IN MEDWATCH 1820334-2018-02359.

  Patient problems: No Code Available

  MAUDE report 7852462 ↗
• InjurySep 6, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER WAS PLACED INTO THE TRANSPLANTED KIDNEY AND BLADDER OF A PATIENT DURING A NEPHROURETERAL DRAINAGE PROCEDURE AT AN UNSPECIFIED DATE. HUB SEPARATION FROM THE CATHETER WAS REPORTED TO HAVE HAPPENED TWO TIMES, ONE WEEK APART. IN THE FIRST OCCURRENCE, IT WAS FOUND POST PROCEDURE THAT THE CATHETER HAD SEPARATED FROM THE HUB. THE DEFECTIVE CATHETER WAS REMOVED AND REPLACED WITH A LIKE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE SECOND OCCURRENCE IS DETAILED IN MEDWATCH 1820334-2018-02532.

  Patient problems: No Code Available

  MAUDE report 7852370 ↗
• InjuryAug 20, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THE PATIENT RETURNED ON (B)(6) 2018 DUE TO LEAKING OF THE ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER . THE DRAINAGE CATHETER WAS INITIALLY PLACED ON (B)(6) 2018 FOR A BILIARY DRAIN PROCEDURE. THE DEVICE WAS SUCCESSFULLY REPLACED WITH A SIMILAR DEVICE FROM A DIFFERENT LOT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7796661 ↗
• InjuryNov 29, 2017Break; Break

  THE CUSTOMER REPORTED THAT THE PATIENT HAD TO RETURN FOR ADDITIONAL MEDICAL INTERVENTION WHEN THE HUB OF THE ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER BROKE FOLLOWING SURGERY. THE DEVICE WAS REPORTEDLY IMPLANTED ON (B)(6) 2017 AND REPLACED ON (B)(6) 2017. ADDITIONAL INFORMATION WAS REQUESTED FROM BUT NOT PROVIDED BY THE CUSTOMER. THE PRODUCT WAS RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Code Available

  MAUDE report 7069242 ↗
• MalfunctionNov 14, 2017Insufficient Device Problem Information

  THE DEVICE LEAKED NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7028198 ↗
• MalfunctionNov 14, 2017Leak/Splash

  THE DEVICE LEAKED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Information

  MAUDE report 7028177 ↗
• MalfunctionNov 9, 2017Component Falling

  THE COMPLAINANT REPORTED THAT A DRESSING WAS BEING PLACED ON THE CATHETER AND THE HUB FELL OFF AFTER THE BILIARY DRAIN PLACEMENT WAS OVER. THE HUB DISCONNECTED WHERE THE CATHETER AND HUB MEET. THE PATIENT WAS STILL ON THE TABLE FROM THE INITIAL CATHETER PLACEMENT. AS A RESULT OF THE MALFUNCTION, THE DOCTOR PLACED A NEW CATHETER AND THE PATIENT WAS ABLE TO LEAVE THE ROOM. THERE WERE NO REPORTS OF ANY SECTION OF THE DEVICE REMAINING INSIDE THE PATIENT'S BODY AND THE INITIAL REPORTER NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS PRODUCT PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7014418 ↗
• InjuryJul 20, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF AN ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER FOR AN UNSPECIFIED INDICATION. THE CUSTOMER REPORTS THAT "THE DRAIN BROKE ITSELF DURING THE PROCEDURE." THE BREAK OCCURRED AT THE "CROSSING OF THE TUBE AND THE MACLOCK SYSTEM." THE DEVICE WAS EXPLANTED AND EXCHANGED WITH A NEW DEVICE DURING THE INITIAL IMPLANT PROCEDURE. THE HANDLING CONDITIONS AND CIRCUMSTANCES SURROUNDING THE EVENT WERE NOT PROVIDED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Code Available

  MAUDE report 6728075 ↗
• MalfunctionApr 18, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTS EXAMINING A NEW DEVICE THAT HAD NOT TOUCHED ANY PATIENT AFTER HAVING A PATIENT WITH MULTIPLE HUB DETACHMENTS OF THE ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER. THE FACILITY DECIDED TO "TEST A FRESHLY OPENED DEVICE (WITH NO PATIENT CONTACT) AND THE HUB POPPED OFF WITH APPROXIMATELY 3 POUNDS OF FORCE." THE TESTING CONDITIONS AND ACTUAL FORCES APPLIED TO THE DEVICE ARE NOT KNOW; THE TEST WAS NOT CONDUTED USING CALIBRATED MEASURING EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT FOR THIS EVALUATION. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF TWO REPORTS BEING SUBMITTED AS THE CUSTOMER REPORTED TWO SEPARATE EVENTS. SEE MDR NUMBERS 1820334-2017-00678 AND 1820334-2017-00679 FOR ALL ASSOCIATED REPORTS. THE SAME CUSTOMER IS INVOLVED FOR BOTH EVENTS.

  Patient problems: No Patient Involvement

  MAUDE report 6501207 ↗