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

Model Number M0061603250

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2015

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a percuflex¿ urinary diversion stent was used during a procedure performed on (b)(6) 2015.According to the complainant, there was no issue during implantation, and the stent had been implanted in the patient for two days.Reportedly, during withdrawal, the pig tail section was found kinked.There were no patient complications reported as a result of this event.The patients¿ condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

The complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4) stent kinked.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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.

Manufacturer Narrative

A visual analysis of the device found the stent pigtail was kink.A functional evaluation was performed and found that the mandrel that was inserted was able to pass through the stent without resistance.The evaluation concluded that the most probable root cause for this event is related to the procedural factors found during the procedure that most likely limited the integrity of the device.It is possible that the kink in the stent could have been generated from the manipulation of the device during the procedure.Therefore, the most probable cause is considered operational context.

Event Description

It was reported to boston scientific corporation that a percuflex¿ urinary diversion stent was used during a procedure performed on (b)(6) 2015.According to the complainant, there was no issue during implantation, and the stent had been implanted in the patient for two days.Reportedly, during withdrawal, the pig tail section was found kinked.There were no patient complications reported as a result of this event.The patients¿ condition at the conclusion of the procedure was reported to be good.

• 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: 4686113
• MDR Text Key: 5714530
• Report Number: 3005099803-2015-01050
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061603250
• Device Catalogue Number: 160-325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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