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

Catalog Number	M001468070
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the returned device found that the guidewire was received in two fragments and the polytetrafluoroethylene (ptfe) coating was scrapped closed to the fracture site.Magnified examination of the fracture site showed the core wire was fractured and the guidewire was kinked.It appears that the guidewire separated due to kinking; likely due to some procedural factors encountered during use.From the condition of the device, the functional test could not be performed.Additional information provided by the customer indicated that guidewire was inspected and confirmed to be in good condition after unpacking and during preparation, the guidewire was prepared per the device direction for use (dfu) instructions and slight resistance was encountered while removing the guidewire from the dispenser hoop.Based on the condition of the fracture and the scrapping of the ptfe coating, it appears that the other anomalies (fracture and ptfe peeling) noted during the device analysis were caused by excessive manipulation during the procedure.Therefore, a cause of 'handling damage" has been assigned to the analyzed codes "guidewire broken" and "guidewire ptfe coating peeling".
Event or Problem Description
Analysis of the returned device revealed that the subject device was received in two fragment and the polytetrafluoroethylene (ptfe) coating was scrapped closed to the fracture site.There was no clinical consequence to the patient as a result.

• 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: 8116118
• Report Number: 3008853977-2018-00067
• Device Sequence Number: 19214326
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 08714729326250
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Report Date (Section B): 11/29/2018

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: 01/18/2020
• Device Catalogue Number: M001468070
• Device Lot Number: 21630433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1