MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) PERCUFLEX¿ URINARY DIVERSION STENT; CATHETER, NEPHROSTOMY

Model Number	M0061603250
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for analysis.Upon 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 supposed to be used for a procedure (exact date not reported).According to the complainant, during unpacking "it was found that the device was not sealed in a sterile bag¿.Reportedly, the device was not received in a sterile device pouch.The device was not used in the procedure, and the procedure was completed with another percuflex¿ urinary diversion stent.There were no patient complications reported as a result of this event.Attempts to obtain details regarding the event description have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
A visual inspection of the returned device revealed that the catheter with adaptor was returned without its packaging, and the device has no visible defects.During manufacturing processes the product is 100% inspected for device functionality and integrity to ensure that all finished devices meet specification, however, there is no control of how the unit was handled in the field.There are processes in place in order to verify that the product was properly assembled, and that it was not possible to generate this type of failure during the manufacturing process.Therefore, a definitive root cause could not be determined.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex¿ urinary diversion stent was supposed to be used for a procedure (exact date not reported).According to the complainant, during unpacking "it was found that the device was not sealed in a sterile bag¿.Reportedly, the device was not received in a sterile device pouch.The device was not used in the procedure, and the procedure was completed with another percuflex¿ urinary diversion stent.There were no patient complications reported as a result of this event.Attempts to obtain details regarding the event description have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: PERCUFLEX¿ URINARY DIVERSION STENT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6546627
• Report Number: 3005099803-2017-01381
• Device Sequence Number: 133446
• Product Code: LJE
• UDI-Device Identifier: 08714729821137
• UDI-Public: (01)08714729821137(17)20190630(10)19799249
• Combination Product (Y/N): N
• PMA/510(K) Number: K830803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2017

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: 06/30/2019
• Device Model Number: M0061603250
• Device Catalogue Number: 160-325
• Device Lot Number: 19799249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1