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

Catalog Number M001468060

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

Subject device is not available.

Event 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 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.

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
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101
• MDR Report Key: 8199855
• MDR Text Key: 131512642
• Report Number: 3008853977-2018-00080
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729201212
• UDI-Public: 08714729201212
• Combination Product (y/n): N
• PMA/PMN Number: K931584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXELSIOR MICROCATHETER STRYKER; EXELSIOR MICROCATHETER STRYKER
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 72 YR