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	09/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable.
Event or Problem Description
It was reported that the middle of the subject device(guidewire) was broken when delivering in the microcatheter.There were no reported clinical consequences to the patient due to this event.
Event or Problem Description
It was reported that the middle of the subject device(guidewire) was broken when delivering in the microcatheter.There were no reported clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The returned guidewire was found to be broken into two segments.Magnified examination of the fracture site showed the core wire was fractured.Additionally, the guidewire was kinked and bent at the proximal and distal side of the fracture site and several places along its ptfe (polytetrafluoroethylene) length.The guidewire ptfe coating was scrapped on the bent section.Functional analysis could not be performed due to the anomalies found on the product.It is likely that the kinking and bending observed during the device inspection was caused by excessive manipulation or handling of the guidewire when trying to deliver it into the microcatheter.Analysis of the returned device found the guidewire appeared to break due to excessive manipulation.Additional information provided by the customer indicated that no damage was noted to the packaging, continuous flush was maintained, no resistance was encountered during the manipulation of the guidewire, torque device was not used on the guidewire and the device was prepared per the device direction for use (dfu) instructions.The information provided by the customer also indicated that the patient's anatomy was slightly tortuous.The device met the product design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during the use, the product performance was limited.Therefore, a cause of 'procedural factors' due to component failure has been assigned to the reported event.Because review of the available information failed to identify a definitive cause and because the torque device was not returned for analysis, the cause of the ptfe peeling cannot be definitely 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: 7912829
• Report Number: 3008853977-2018-00052
• Device Sequence Number: 2052386
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 08714729326250
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 11/12/2018

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: 12/08/2019
• Device Catalogue Number: M001468070
• Device Lot Number: 21489807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (HEADWAY)
• Patient Age: 62 YR