MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M0061453620
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was open to be used during a ureteral lithotripsy procedure in the kidney performed on (b)(6) 2020.According to the complainant, when the physician unpacked the device, it was noticed that the stent was fractured.The procedure was successfully completed with another percuflex plus ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was open to be used during a ureteral lithotripsy procedure in the kidney performed on (b)(6) 2020.According to the complainant, when the physician unpacked the device, it was noticed that the stent was fractured.The procedure was successfully completed with another percuflex plus ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital initial reporter state: hubei province block h6: device code 1069 captures the reportable event of stent shaft broken.Block h10: the returned percuflex ureteral stent was analyzed, and a visual evaluation noted that the proximal section (bladder pigtail) detached.The stent was returned without the suture and the detached bladder pigtail section.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that the bladder pigtail was detached.The condition of the device, bladder pigtail detached, could be interpreted by the customer as stent shaft break.According to the device analysis, the stent was returned without the suture and the detached bladder pigtail section.Evidence that the stent was manipulated.The failure found, bladder pigtail detached, is an issue that could have been generated by the user or due to the interaction of the device with the suture string.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the preparation and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: PERCUFLEX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10627100
• Report Number: 3005099803-2020-04391
• Device Sequence Number: 19634479
• Product Code: FAD
• UDI-Device Identifier: 08714729040330
• UDI-Public: 08714729040330
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K834468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: M0061453620
• Device Catalogue Number: 145-362
• Device Lot Number: 0024793066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 65