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

Model Number M0064001160

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/12/2017

Event Type  malfunction  

Event Description

After inserting open ended catheter through cystoscope and into patient, surgeon withdrew the catheter slightly.Stated something was wrong.It was apparent that the catheter had broken in half.Both pieces were retrieved.Packaging and product saved.No injury to the patient.

• Brand Name: OPEN END URETERAL AXXCESS CATHETER
• Type of Device: CATHETER, URETHRAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6968266
• MDR Text Key: 89940642
• Report Number: 6968266
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/14/2021
• Device Model Number: M0064001160
• Device Lot Number: 21013182
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; NOT APPLICABLE.
• Patient Age: 35 YR
• Patient Weight: 83