MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 014/205 FLOPPY; WIRE, GUIDE, CATHETER

Catalog Number	M001468070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure while advancing the subject guidewire through the microcatheter, resistance was felt.While attempting to remove the guidewire, a strong kink was felt and it broke.The procedure was completed with another product without any problem.No clinical consequences were reported to the patient.
Event or Problem Description
It was reported that during the procedure while advancing the subject guidewire through the microcatheter, resistance was felt.While attempting to remove the guidewire, a strong kink was felt and it broke.The procedure was completed with another product without any problem.No clinical consequences were reported to the patient.
Additional Manufacturer Narrative
Expiration date: added product available to stryker and returned date: updated device evaluated by mfg :update summary attached: updated : manufacturing date: added the device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the device revealed that that the guidewire was received in two fragments: the proximal fragment was measured to be approximately 46.3cm in length and the distal fragment was approximately 157.4cm in length.Magnified examination of the fracture site showed the core wire was fractured.The guidewire was bent (kinked) at the fracture site.The guidewire was also bent just distal to the fracture site.No stretching on the the guidewire was found.From the condition of the guidewire at the fracture site, it appears that the guidewire separated due to excessive bending, kinking/manipulation.The condition of the returned guidewire observed during product inspection suggests that excessive torque and manipulation during use resulted in the observed damage.Due to this observation, an assignable cause of handling damage was assigned to the reported guidewire friction, kink and fracture.In addition, the guidewire polytetrafluoroethylene (ptfe) coating was examined under magnification.The ptfe was scraped just proximal to the fracture site, no other anomalies were observed with the ptfe coating.Functional analysis was not be performed due to the anomalies found on the product.Additional information provided by the customer indicated that the procedure was completed successfully using the same microcatheter.The torque device was not returned back with the device and could not be inspected to determine if its use contributed to the ptfe peeling, as a result, therefore the cause of the analyzed ptfe coating peeling could not be determined.

• Brand Name: TRANSEND EX 014/205 FLOPPY
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101
• MDR Report Key: 8238591
• Report Number: 3008853977-2019-00009
• Device Sequence Number: 11158811
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 08714729326250
• Combination Product (Y/N): N
• PMA/510(K) Number: K944677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2019

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: 06/06/2020
• Device Catalogue Number: M001468070
• Device Lot Number: 22221567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 01/10/2019
• Supplement Report FDA Received Date: 02/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1