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

Catalog Number M001468060

Device Problems Break (1069); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2018

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Visual inspection of the returned device found that the guidewire was received in two fragments.Magnified examination of the fracture site showed the core wire was fractured and the guidewire was kinked.Additionally, the polytetrafluoroethylene (ptfe) coating was scrapped closed to the fracture site.From the condition of the device, the functional test could not be performed.Analysis of the device revealed bending at the fracture site which is an indication of excessive manipulation during use.From the condition of the fracture, it appears that the guidewire kinked and then separated due to handling.Therefore, a probable cause of handling damage has been assigned to the reported and analyzed ¿guidewire broken and kinked'.It is possible the ptfe coating was damaged due to insecure tightening of the torque device.However, this could not be definitively assessed since the torque device was not returned for analysis.Therefore, a cause of undeterminable has been assigned to the reported and analyzed ¿guidewire ptfe coating peeling'.

Event Description

Analysis of the returned device found that the subject device guidewire was broken and the ptfe (polytetrafluoroethylene) coating was peeled.There was no clinical consequence to the patient as a result.

• Brand Name: TRANSEND EX 014/205 SOFT TIP
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101
• Manufacturer (Section G): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 8188652
• MDR Text Key: 131123908
• Report Number: 3008853977-2018-00079
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729201212
• UDI-Public: 08714729201212
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K931584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2020
• Device Catalogue Number: M001468060
• Device Lot Number: 21681085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1