MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPEN END URETERAL AXXCESS CATHETER; CATHETER, URETHRAL

Model Number	M0064001161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an axxcess ureteral catheter open end was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, during removal of the device, it was noted that the catheter was sliced in half.Reportedly, part of the device had detached in the ureter of the patient and was retrieved using graspers.The procedure was completed at this time.Additionally, it was suspected that the problem is due to cutting the device from the scope.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: OPEN END URETERAL AXXCESS CATHETER
• Common Device Name: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8817265
• Report Number: 3005099803-2019-03748
• Device Sequence Number: 3027230
• Product Code: GBM
• UDI-Device Identifier: 08714729191971
• UDI-Public: 08714729191971
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K830840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0064001161
• Device Catalogue Number: 400-116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention