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

Model Number M0061603300

Device Problems Break (1069); Calcified (1077)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report lot number; therefore, the manufacture date and expiration date are unknown.Reported event of stent broken.Reported event of stent calcified.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.

Event Description

It was reported to boston scientific corporation that a percuflex¿ urinary diversion stent was used during a stent replacement procedure on an unknown date.According to the complaint while removing the previously implanted percuflex¿ urinary diversion stent, the stent was found calcified and broken along the shaft, but it did not completely detach.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 additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

A visual analysis of the returned device found that the stent was broken 12.0cm from the distal tip, and was calcified.The evaluation confirmed that the calcification was noted inside and outside the catheter.It is possible that the calcification could have been generated when the device remains in the patient's body for a certain time.The returned device has evidence of excessive stretching and eventual bursting as mode of stent failure.Due to anatomical and/or procedural factors encountered during the procedure, performance was limited.Therefore, the most probable root cause of this complaint is operational context.

Event Description

It was reported to boston scientific corporation that a percuflex¿ urinary diversion stent was used during a stent replacement procedure on an unknown date.According to the complaint while removing the previously implanted percuflex¿ urinary diversion stent, the stent was found calcified and broken along the shaft, but it did not completely detach.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 additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 6574532
• MDR Text Key: 75412499
• Report Number: 3005099803-2017-01419
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2017

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
• Device Operator: Health Professional
• Device Model Number: M0061603300
• Device Catalogue Number: 160-330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2017
• Initial Date FDA Received: 05/17/2017
• Supplement Dates Manufacturer Received: 07/14/2017
• Supplement Dates FDA Received: 08/08/2017
• 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