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

Model Number M0061602050

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/12/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a percuflex¿ urinary diversion stent set was implanted in the patient's left kidney during a radical cystectomy ileoconduit (bricker) procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2014, during the removal of the stent, the tip of the stent was found to be missing.Ct scan was performed which confirmed the detached coil part of the stent was left inside the patient.On (b)(6) 2014, an interventional radiologist successfully removed the detached coil percutaneously with the use of a snare (manufacturer unknown).However, it took approximately three hours to remove the remaining tip because the coil had split in two pieces.Reportedly, the indication for the procedure was invasive muscle bladder cancer.The patient's condition at the conclusion of the procedure was reported to be stable but has fever.

Manufacturer Narrative

(b)(4) stent detached.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 set was implanted in a (b)(6) male patient's left kidney during a radical cystectomy ileoconduit (bricker) procedure on (b)(6) 2014.Reportedly, the indication for the procedure was invasive muscle bladder cancer.Although the patient underwent chemotherapy prior to the procedure, he did not undergo any chemo or radiation therapy after the stent was implanted.During a procedure on (b)(6) 2014, the stent was removed without any difficulty.However, after the stent was removed it was determined that the tip of the stent had detached in the patient during the removal process.A ct scan confirmed that a piece of the stent was left inside the patient.On (b)(6) 2014, an interventional radiologist successfully removed the detached coil percutaneously with the use of a snare (manufacturer unknown).The removal procedure took approximately three hours due to the remaining coil tip being split in two pieces.The patient had a fever at the conclusion of procedure, and it was reported that his condition was "good".

Manufacturer Narrative

A visual evaluation of the returned device found the device to be blackened with a damaged extrusion and a missing tip.The cap connector was not returned.A functional inspection was not performed due to the condition of the returned device.The section of breakage showed evidence of tension/torsion overload on a previously cracked area.The investigation concluded that this complaint is associated with a product that meets design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.There is evidence that the mode of separation of the device was produced by tension/torsion overload during the procedure that may have caused the failure reported.Therefore, the most probable root cause classification for the reported failure is operational context.A search of the complaint database revealed that no similar complaints exist for the specified lot.The device history record review found the device met all manufacturing specifications.A labeling review was performed and no anomaly was found.

Event Description

It was reported to boston scientific corporation that a percuflex¿ urinary diversion stent set was implanted in the patient's left kidney during a radical cystectomy ileoconduit (bricker) procedure performed on (b)(6) 2014.According to the complainant, on (b)(6) 2014, during the removal of the stent, the tip of the stent was found to be missing.Ct scan was performed which confirmed the detached coil part of the stent was left inside the patient.On (b)(6) 2014, an interventional radiologist successfully removed the detached coil percutaneously with the use of a snare (manufacturer unknown).However, it took approximately three hours to remove the remaining tip because the coil had split in two pieces.Reportedly, the indication for the procedure was invasive muscle bladder cancer.The patient's condition at the conclusion of the procedure was reported to be stable but has fever.

• Brand Name: PERCUFLEX? URINARY DIVERSION STENT SET
• 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: 4244164
• MDR Text Key: 19804002
• Report Number: 3005099803-2014-03540
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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,Followup
• Report Date: 10/13/2014

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 Expiration Date: 01/25/2015
• Device Model Number: M0061602050
• Device Catalogue Number: 160-205
• Device Lot Number: 0014071123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2015
• Initial Date FDA Received: 11/11/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/08/2015; 03/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2011
• 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
• Patient Age: 71 YR