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

Model Number	M0061453720
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state: (b)(6).(b)(4).He 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 on november 22, 2019 that a percuflex ureteral stent was used during a percutaneous nephrolithotomy procedure performed on (b)(6) 2019.According to the complainant, when the device was unpacked the stent was fractured.The procedure was completed with another percuflex 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 state: (b)(6).Block h6: device code 1069 has been selected to represent the reportable event of stent shaft break.Block h10: one percuflex ureteral stent was returned with the bladder pigtail torn.The suture was not returned for analysis.It is evident that the stent was manipulated; therefore the failure found, bladder pigtail torn, is an issue that could have been generated by the user or due to the interaction of the device with the suture string.The most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the preparation and the device had no influence on event.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 event.All compiled information on this investigation determines that the most probable cause is: adverse event related to procedure.A dhr (device history record) review was performed and no anomalies were observed, the review confirmed that the device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a percuflex ureteral stent was used during a percutaneous nephrolithotomy procedure performed on (b)(6) 2019.According to the complainant, when the device was unpacked the stent was fractured.The procedure was completed with another percuflex 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.

• Brand Name: PERCUFLEX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 9481645
• Report Number: 3005099803-2019-06041
• Device Sequence Number: 3541402
• Product Code: FAD
• UDI-Device Identifier: 08714729040392
• UDI-Public: 08714729040392
• 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): 01/30/2020

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: 08/13/2022
• Device Model Number: M0061453720
• Device Catalogue Number: 145-372
• Device Lot Number: 0024265386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 76