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	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during a coil embolization of an aneurysm located at the right cavernous internal carotid artery (ica), a guidewire (subject device) together with a microcatheter were advanced within the vasculature.The physician tried to loop the wire in the aneurysm sac in order to try to get across the neck of the aneurysm.The 3cm guidewire tip broke off inside the aneurysm.The physician realized that the guidewire broke when he wanted to do a run after withdrawing the guidewire from the microcatheter and he noticed that there was no flow of flushing.The physician planned to use a snare device to retrieve the broken part of the guidewire but seeing the tortuosity of the vessel, he decided to sacrifice the vessel by deploying a detachable balloon.After balloon deployment, there is still good collateral blood flow into the right side of brain.
Event or Problem Description
It was reported that during a coil embolization of an aneurysm located at the right cavernous internal carotid artery (ica), a guidewire (subject device) together with a microcatheter were advanced within the vasculature.The physician tried to loop the wire in the aneurysm sac in order to try to get across the neck of the aneurysm.The 3cm guidewire tip broke off inside the aneurysm.The physician realized that the guidewire broke when he wanted to do a run after withdrawing the guidewire from the microcatheter and he noticed that there was no flow of flushing.The physician planned to use a snare device to retrieve the broken part of the guidewire but seeing the tortuosity of the vessel, he decided to sacrifice the vessel by deploying a detachable balloon.After balloon deployment, there is still good collateral blood flow into the right side of brain.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The device was returned the guidewire was separated at approximately 197.0cm from its proximal end.The guidewire separated distal fragment was not returned.Magnified examination of the fracture site showed the core wire and polymer sleeve were fractured.No stretching on the polymer was found.No stretching on the the guidewire (core wire) was found.The guidewire was bent approximately 4.5cm proximal to the fracture site.The guidewire was bent on several places along its ptfe length.The guidewire polytetrafluoroethylene (ptfe) coating was examined.The ptfe was also scraped on several places along its proximal approximately 40.0cm length from its proximal end.The coating is present on the guidewire and meets visual specifications.The bending and fracture on the guidewire appeared to be due to excessive manipulation.Functional analysis was not be performed due to the anomalies found on the product.The guidewire was separated on its distal section.The transend guidewire fracture surface was inspected using a scanning electron microscope (sem).The inspection of the fracture surface revealed ductile dimples consistent with a torsional fracture mode.This suggests excessive manipulation during torqueing of the device during use.Additional information provided by the customer indicated that the guidewire was prepared as per the dfu.The torque device was not returned back with the device and could not be inspected to determine if its use contributed to the ptfe peeling, as a result, the cause of "undeterminable" has been assigned to the as analyzed guidewire ptfe coating peeling.The condition of the returned guidewire observed during product inspection suggests that excessive torque and manipulation during use resulted in the observed damage.Therefore, an assignable cause of "human factors (handling)" has been assigned to reported and analyzed code guidewire break, the reported guidewire - un-retrieved device fragments and the analyzed guidewire kink.

• 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: 8199855
• Report Number: 3008853977-2018-00080
• Device Sequence Number: 16626570
• 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): 02/08/2019

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: 05/06/2020
• Device Catalogue Number: M001468060
• Device Lot Number: 22087436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 02/08/2019
• 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: EXELSIOR MICROCATHETER STRYKER; EXELSIOR MICROCATHETER STRYKER
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR