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

Catalog Number	M001468080
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during procedure, the tip of the guidewire broke off inside patient in the carotid artery and had to be retrieved with a snare device.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned device and it was observed that the guidewire was received in two fragments; the guidewire was bent at the fracture site and the platinum coil was stretched.Functional could not be performed based on damage to product.From the condition of the guidewire at the fracture site, it appears that the guidewire may have separated due to over torqueing and bending, which may have occurred due to excessive manipulation of the guidewire through the moderately tortuous anatomy.It is likely that the kink observed at the proximal section during the product analysis was also caused due to excessive manipulation and torqueing of the guidewire.The reported event was confirmed based on the product analysis.It is probable that the device was damaged during the clinical procedure due to some procedural/anatomical factors encountered causing the as reported event, therefore assignable cause of procedural factors will be assigned to reported issue.
Event or Problem Description
It was reported that during procedure, the tip of the guidewire broke off inside patient in the carotid artery and had to be retrieved with a snare device.There were no clinical consequences to the patient.

• Brand Name: TRANSEND EX 014/205 PLATINUM
• 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: 8303424
• Report Number: 3008853977-2019-00014
• Device Sequence Number: 18848496
• Product Code: DQX
• UDI-Device Identifier: 08714729326267
• UDI-Public: 08714729326267
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K971254
• 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): 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2020
• Device Catalogue Number: M001468080
• Device Lot Number: 22553066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 04/05/2019
• 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: VELOCITY MICROCATHETER (PENUMBRA)
• Outcome Attributed to Adverse Event: Required Intervention