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

Model Number M0061603250

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

Exact patient age unknown, but patient reported to be in his 40¿s.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.(b)(4).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 the percuflex urinary diversion stent implanted on (b)(6) 2015 was found occluded on (b)(6) 2015.Reportedly the occlusion was caused by debris, and the debris was removed at bedside using a "wire" and cleaning.According to the complainant, on (b)(6) 2015, a catheter replacement procedure was performed with the aid of fluoroscopy to replace the occluded catheter, however, "catheter was noted to be detached." the broken part of the catheter, approximately 8cm was difficult to remove, thus, they decided to schedule the removal on (b)(6) 2015.On (b)(6) 2015, the detached part was successfully removed from the patient and the patient's current condition was reported to be stable.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 evaluation of the returned device found that the stent was separated into two sections and the first sideport hole from the proximal section was broken.The investigation concluded that conditions due to anatomical and/or procedural factors encountered during the procedure can cause the device to fail.Most likely, an excessive force was applied on the catheter during the procedure causing the stent to break.Therefore, the most probable root cause is ¿operational context.¿ a labeling review was performed no anomaly was found.

Event Description

It was reported to boston scientific corporation that the percuflex urinary diversion stent implanted on (b)(6) 2015 was found occluded on (b)(6) 2015.Reportedly the occlusion was caused by debris, and the debris was removed at bedside using a "wire" and cleaning.According to the complainant, on (b)(6) 2015, a catheter replacement procedure was performed with the aid of fluoroscopy to replace the occluded catheter, however, catheter was noted to be detached.The broken part of the catheter, approximately 8cm was difficult to remove, thus, they decided to schedule the removal on (b)(6) 2015.On (b)(6) 2015, the detached part was successfully removed from the patient and the patient's current condition was reported to be stable.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: 5061335
• MDR Text Key: 25172789
• Report Number: 3005099803-2015-02567
• 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: Followup
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• 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
• Patient Outcome(s): Required Intervention