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

Model Number	M006175253180
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 stent was used for a procedure performed on (b)(6) 2018.According to the complainant, during unpacking it was noticed that the stent was broken into two pieces.The box and bag that the stent arrived in was noted to have no visible damage.The procedure was completed with another stent of a different size.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.
Additional Manufacturer Narrative
A percuflex plus stent was returned for analysis.A visual analysis of the returned device found that the bladder pigtail was detached.No other anomalies or damages were noted.The complaint was confirmed.Based on product analysis, the failure was noted to have occurred outside the patient and t during unpacking.It is possible that the device was handled and manipulated in a way that contributed to the failure encountered -stent detached, and the defect could have been caused by the user due to excessive manipulation and interaction of the stent with suture.This type of failure is consistent with one caused when a device is pulled strongly and was submitted to an excess of force; excess of force may cause damage, deformities or device break.Therefore, the most probable root cause of this complaint is handling damage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus stent was used for a procedure performed on (b)(6) 2018.According to the complainant, during unpacking it was noticed that the stent was broken into two pieces.The box and bag that the stent arrived in was noted to have no visible damage.The procedure was completed with another stent of a different size.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¿ 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: 7423548
• Report Number: 3005099803-2018-01103
• Device Sequence Number: 13630554
• Product Code: FGE
• UDI-Device Identifier: 08714729772736
• UDI-Public: 08714729772736
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: M006175253180
• Device Catalogue Number: 175-253-18
• Device Lot Number: 21685341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1