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

Model Number	M0061752810
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used to be used for a ureteroscopy procedure to be performed in the ureter on (b)(6) 2018.According to the complainant, during preparation, the stent broke in half along the shaft.The procedure was completed with another percuflex plus stent.There was no serious injury nor were there any adverse patient effects as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used to be used for a ureteroscopy procedure to be performed in the ureter on (b)(6) 2018.According to the complainant, during preparation, the stent broke in half along the shaft.The procedure was completed with another percuflex plus stent.There was no serious injury nor were there any adverse patient effects as a result of this event.
Additional Manufacturer Narrative
Problem code 1069 captures the reportable event of  stent broken.  a percuflex plus stent was returned for analysis.A visual analysis of the returned device found that it was separated/broken at the distal section (near to the renal pigtail).The suture string was not returned for analysis.No other anomalies were noted.Based on the analysis performed on the condition of the returned device, and all gathered information, it is possible that the failure encountered (stent separated/broken) was associated with the interaction of the stent with its suture.Therefore, a conclusion code of unintended use error caused or contributed to event is selected for this event, since the interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8131230
• Report Number: 3005099803-2018-61779
• Device Sequence Number: 1770950
• Product Code: FAD
• UDI-Device Identifier: 08714729067924
• UDI-Public: 08714729067924
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K924608
• 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,Followup
• Report Date (Section B): 01/31/2019

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: 06/19/2021
• Device Model Number: M0061752810
• Device Catalogue Number: 175-281
• Device Lot Number: 0022277006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1