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

Model Number	M0061453730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
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
Note: this report pertains to one of three devices used during the same procedure.It was reported to boston scientific corporation that a percuflex stent was to be used for a cystoscope room for bladder examination and placement of ureteral stent procedure, to be performed in the bladder and ureter on (b)(6) 2019.According to the complainant, during unpacking, it was noticed that the stent was broken along the shaft.The procedure was cancelled and was rescheduled due to this event.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to one of three devices used during the same procedure.It was reported to boston scientific corporation that a percuflex stent was to be used for a cystoscope room for bladder examination and placement of ureteral stent procedure, to be performed in the bladder and ureter on (b)(6) 2019.According to the complainant, during unpacking, it was noticed that the stent was broken along the shaft.The procedure was cancelled and was rescheduled due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Device code 1069 captures the reportable event of stent shaft broken.Investigation analysis: a percuflex stent was returned for analysis.A visual evaluation of the returned device found that the middle section detached.Additionally, the bladder pigtail was observed detached.The most proximal section of the stent and the suture string were not returned for analysis.The failure found (stent detached) is an issue that could have been generated by the user or due to the interacting of the device with the suture string or other devices used in the same procedure.Therefore, "adverse event related to procedure" is selected as the most probable root cause for the complaint.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
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8531574
• Report Number: 3005099803-2019-02077
• Device Sequence Number: 19291721
• Product Code: FAD
• UDI-Device Identifier: 08714729040408
• UDI-Public: 08714729040408
• 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): 06/21/2019

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: 11/08/2020
• Device Model Number: M0061453730
• Device Catalogue Number: 145-373
• Device Lot Number: 0021361785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 64