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

Catalog Number	M001468060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During embolization procedure of internal carotid artery (ica) aneurysm, it was reported that the resistance was felt during insertion of the guidewire (subject device) into the non-stryker microcatheter, then more force was applied to push in the guidewire which caused the guidewire to be kinked and broken at the proximal part of the guidewire.The broken guidewire was removed safely from the patient without any adverse consequences.The procedure was completed with a new set and the patient was reported to be in stable condition following the procedure.No further information is available.
Additional Manufacturer Narrative
The edhr (electronic device history record) for the device lot is created and maintained in mes (manufacturing execution system).Automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During analysis, the guidewire was found to be separated from its proximal end.Magnified examination of the fracture site showed the corewire was fractured and the guidewire was bent just proximal and distal to the fracture site.The ptfe (polytetrafluoroethylene) coating was also found to be scraped close to the fracture site.Functional analysis was not be performed due to the anomalies found on the product.It could not be determined whether the microcatheter contributed to the reported friction since the device was not returned.Additional information provided by the customer indicated that no anomalies were noted to the device after removal from its packaging, the guidewire was prepared as per the directions for use (dfu), resistance was felt during insertion of the guidewire into the microcatheter and force was applied to overcome the resistance causing the wire to kink and break.From the condition of the fracture, it appears the guidewire kinked and then separated due to bending and excessive manipulation during use to overcome the reported resistance.The scraped ptfe coating surrounding the fracture site appears to be associated with the fracture.As a result, a probable cause of handling damage has been assigned to this investigation.
Event or Problem Description
During embolization procedure of internal carotid artery (ica) aneurysm, it was reported that the resistance was felt during insertion of the guidewire (subject device) into the non-stryker microcatheter, then more force was applied to push in the guidewire which caused the guidewire to be kinked and broken at the proximal part of the guidewire.The broken guidewire was removed safely from the patient without any adverse consequences.The procedure was completed with a new set and the patient was reported to be in stable condition following the procedure.No further information is available.

• Brand Name: TRANSEND EX 014/205 SOFT TIP
• 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: 8600861
• Report Number: 3008853977-2019-00039
• Device Sequence Number: 11262132
• Product Code: DQX
• UDI-Device Identifier: 08714729201212
• UDI-Public: 08714729201212
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 06/13/2019

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: 10/18/2020
• Device Catalogue Number: M001468060
• Device Lot Number: 22815347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 06/08/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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: HEADWAY 21 MICROCATHETER; HEADWAY 21 MICROCATHETER
• Patient Age: 61 YR