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

Model Number	M0061603250
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.Initial reporter state: (b)(6).(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex urinary diversion stent was used in an unknown procedure on (b)(6) 2020.According to the complainant, during the procedure, withdrawal/closure of the procedure, the stent was broken about 15 cm from the pigtail.Reportedly, the broken stent was removed and there were no fragments of the percuflex urinary diversion stent left inside the patient.There were no patient complications reported as a result of this event.

• 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: 10367636
• Report Number: 3005099803-2020-03141
• Device Sequence Number: 2888391
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2020

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 Model Number: M0061603250
• Device Catalogue Number: 160-325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1