MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX URINARY DIVERSION STENT; CATHETER, NEPHROSTOMY

Model Number	M0061603250
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
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 urinary diversion stent was implanted in the kidney and bladder for a total cystectomy procedure on an unknown date.According to the complainant, one week after the operation on (b)(6) 2019, during withdrawal, the stent was removed.It was reported that the stent was indwelled in a situation where there was a loop in the new bladder.The stent was noticed to be detached in the bladder side.The detached stent was completely removed through the use of a cystoscope.There were no adverse patient effects reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex urinary diversion stent was implanted in the kidney and bladder for a total cystectomy procedure on an unknown date.According to the complainant, one week after the operation on (b)(6), 2019, during withdrawal, the stent was removed.It was reported that the stent was indwelled in a situation where there was a loop in the new bladder.The stent was noticed to be detached in the bladder side.The detached stent was completely removed through the use of a cystoscope.There were no adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
Device problem code 2907 captures the reported event of stent detached.Investigation analysis: a percuflex urinary diversion stent was returned for analysis.A visual evaluation of the returned device revealed that the shaft was detached (both sections of the detached are stretch) near to the pigtail section.Consequently; confirming the reported complaint.The failure found (stent detached and stretch) is an issue that could have been generated by the user if the device was pulled until it was separated.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.Correction to initial reporter city: updated to (b)(6).Correction to initial reporter address: updated to (b)(6).Correction to initial reporter zip/post code: updated to (b)(6).

• Brand Name: PERCUFLEX URINARY DIVERSION STENT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8505867
• Report Number: 3005099803-2019-01878
• Device Sequence Number: 198099
• Product Code: LJE
• UDI-Device Identifier: 08714729821137
• UDI-Public: 08714729821137
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: M0061603250
• Device Catalogue Number: 160-325
• Device Lot Number: 0023255203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention