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

Model Number M0061603350

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual analysis of the returned device found that the stent's pigtail was kinked.The proximal section of the stent was broken and the hub was not returned.The investigation concluded that the most probable root cause for this event is related to handling of the device during preparation.Therefore, the most probable root cause is "handling damage." a review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a percuflex¿ urinary diversion stent was used during a procedure performed (exact date unknown).According to the complainant, during unpacking, they noticed that the stent was bent/kinked.There were no patient complications reported as a result of this event.The patient¿s condition at the conclusion of the procedure was reported to be ¿stable¿.Investigation results revealed that the stent was broken, therefore this event has been deemed an mdr reportable event.

• Brand Name: PERCUFLEX¿ URINARY DIVERSION STENT
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5245973
• MDR Text Key: 32004213
• Report Number: 3005099803-2015-03332
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• PMA/PMN Number: K830803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/03/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: M0061603350
• Device Catalogue Number: 160-335
• Device Lot Number: 18202184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1