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	06/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
During aneurysm embolization, the physician could not advance the guidewire (subject device) in the microcatheter.The guidewire and microcatheter were removed and the physician found the guidewire had broken.There were no clinical consequences to the patient.
Event or Problem Description
During aneurysm embolization, the physician could not advance the guidewire (subject device) in the microcatheter.The guidewire and microcatheter were removed and the physician found the guidewire had broken.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the guidewire was fractured and bent.In addition, the guidewire ptfe (polytetrafluoroethylene) coating was scraped.Functional analysis was not be performed due to the anomalies found on the product.Additional information provided by the customer indicated that the device was prepared per the dfu (direction for use).From the condition of the guidewire, the anomalies on the device appear to be the result of excessive manipulation.Additionally, because this complaint appears to be associated with handling of the product or portion of the product during the procedure a probable cause of handling damage was assigned to the reported and analyzed guidewire broken/fractured inside patient, and the analyzed guidewire kinked/bent.The torque device was not returned with the guidewire, so the cause of the ptfe coating peeling could not be 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: 8725322
• Report Number: 3008853977-2019-00052
• Device Sequence Number: 2522767
• Product Code: DQX
• UDI-Device Identifier: 08714729326250
• UDI-Public: 08714729326250
• Combination Product (Y/N): N
• PMA/510(K) Number: K944677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2019

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: 09/24/2020
• Device Catalogue Number: M001468070
• Device Lot Number: 22299901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 08/26/2019
• 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: SL-10 (STRYKER); SL-10 (STRYKER)