MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) PERCUFLEX¿ PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M0061752520
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 or Problem Description
It was reported to boston scientific corporation that a percuflex¿ plus ureteral stent was used in the ureter during a lithotripsy procedure performed on (b)(6) 2017.According to the complainant, during introduction, the stent was detached inside the patient.The detached piece was successfully removed with forceps.The procedure was completed with another percuflex¿ plus ureteral stent.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.¿.
Additional Manufacturer Narrative
A visual analysis of the returned percuflex¿ plus ureteral stent found that the distal end of renal pigtail of the stent was detached and was not returned.No other anomalies or damages were noted to the stent.The evaluation confirmed that the distal end of renal pigtail of the stent was detached.Based on all available information, and since the event is due to a known effect of the procedure or the use of the device noted within the directions for use, the most probable root cause is "anticipated procedural complication".The device history record (dhr) review found that the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.A labeling review was performed and no anomaly was found.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex¿ plus ureteral stent was used in the ureter during a lithotripsy procedure performed on (b)(6) 2017.According to the complainant, during introduction, the stent was detached inside the patient.The detached piece was successfully removed with forceps.The procedure was completed with another percuflex¿ plus ureteral stent.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¿.

• Brand Name: PERCUFLEX¿ PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6535811
• Report Number: 3005099803-2017-01236
• Device Sequence Number: 954428
• Product Code: FGE
• UDI-Device Identifier: 08714729056805
• UDI-Public: (01)08714729056805(17)20180812(10)0018272373
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2018
• Device Model Number: M0061752520
• Device Catalogue Number: 175-252
• Device Lot Number: 0018272373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention