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 Patient Involvement (2645)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation for the procedure, the guidewire was found to be broken on the proximal section when removed from the dispenser hoop.The physician replaced it with a new guidewire and completed the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Manufacturing date: added, device evaluated by mfg: updated, summary attached: updated, expiration date: added.The device history record review confirms that the device met all material, assembly and performance specifications.The microcatheter and torque device used with the guidewire were not returned.Visual inspection revealed that the guidewire was received in two fragments.Magnified examination of the fracture site showed the core wire was fractured.The guidewire was bent (kinked) at the fracture site and the guidewire was also bent just proximal and distal to the fracture site as well.The device was kinked at approximately 7.5cm from its distal end and bent along its polymer sleeve length.The ptfe (polytetrafluoroethylene) coating was also found to be scraped close to the fracture site of the guidewire.Functional testing could not be performed due to the damaged condition of the returned guidewire.The bending and fracture on the guidewire appeared to be due to excessive manipulation.Information available indicated that resistance was felt when pulling the wire out from the dispenser hoop and the wire separated following removal.Analysis of the device revealed bending at the fracture site which is an indication of excessive manipulation.From the condition of the fracture, it appears that the guidewire was kinked, scraped, and then separated due to excessive force applied to overcome the reported resistance during removal from the dispenser hoop.Therefore based on all of the information available, an assignable cause of handling damage was assigned to the observed and reported damages.
Event or Problem Description
It was reported that during preparation for the procedure, the guidewire was found to be broken on the proximal section when removed from the dispenser hoop.The physician replaced it with a new guidewire and completed the procedure without clinical consequences to the patient.

• 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: 8075990
• Report Number: 3008853977-2018-00062
• Device Sequence Number: 2262313
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 08714729326250
• Combination Product (Y/N): N
• PMA/510(K) Number: K931584
• 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): 01/04/2019

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: 08/29/2019
• Device Catalogue Number: M001468070
• Device Lot Number: 21068005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2018
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR