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

Model Number	M006175263080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).A guidewire was returned for analysis.A visual analysis of the returned device, found that it was broken at 128.0 cm from the proximal end, also the coating was peeled near the broken section, however the device does not have kinks or bent sections.The complaint of guidewire bent was not confirmed.Based on product analysis, the failure was noted during unpacking and outside the patient, however, the device conditions of wire broken and coating peeled, suggest that the device was used.It is most likely some procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.It is also most likely that during procedure the device could have been manipulated, since the failures found are issues that could have been generated by excessive manipulation of the device by the user, also interaction with other devices might have impacted the integrity of the device during the procedure.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.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.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex¿ plus stent has to be used in a procedure.According to the complainant, during unpacking, the guidewire was found to be bent.The procedure was completed with another percuflex¿ plus stent kit.There were no patient complications reported as a result of this event.This event has been deemed an mdr-reportable event based on investigation results which revealed that the guidewires¿ core wire was broken.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex¿ plus stent has to be used in a procedure.According to the complainant, during unpacking, the guidewire was found to be bent.The procedure was completed with another percuflex¿ plus stent kit.There were no patient complications reported as a result of this event.This event has been deemed an mdr-reportable event based on investigation results which revealed that the guidewires¿ core wire was broken.
Additional Manufacturer Narrative
Corrected investigation results: a guidewire was returned for analysis.A visual analysis of the returned device, found that it was broken at 128.0 cm from the proximal end, also the coating was peeled near the broken section, however the device does not have kinks or bent sections.The complaint of guidewire bent was not confirmed.Based on product analysis, the failure was noted during procedure and inside the patient, however, the device conditions of wire broken and coating peeled, suggest that the device was used.It is most likely some procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.It is also most likely that during procedure the device could have been manipulated, since the failures found are issues that could have been generated by excessive manipulation of the device by the user, also interaction with other devices might have impacted the integrity of the device during the procedure.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.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.

• 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: 7474317
• Report Number: 3005099803-2018-01307
• Device Sequence Number: 1233386
• Product Code: FGE
• UDI-Device Identifier: 08714729297420
• UDI-Public: 08714729297420
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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 Model Number: M006175263080
• Device Catalogue Number: 175-263-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2018
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 04/30/2018
• 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