MAUDE Adverse Event Report: AV-TEMECULA-CT 0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE

Catalog Number	1020014
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis.The reported detachment was able to be confirmed.The reported difficult to remove and the reported failure to advance the device were unable to be replicated in a testing environment as they were based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported/noted difficulties appear to be related to circumstances of the procedure as it is likely that as the guide wire was advanced interaction with the previously implanted stent resulted in the reported failure to advance and the reported difficult to remove.Manipulation of the device resulted in the reported/noted detachments (core, coils) and the noted stretched coils.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left circumflex (lcx) artery with no tortuosity and no calcification.A hi-torqure (ht) turntrac guide wire was advanced and resistance was felt in an area where an unspecified stent was previously implanted approximately one year ago and could not reach the lcx.The tip of the ht turntrac guide wire became stuck in the area, during an attempt to pull the guide wire back resistance was felt with the anatomy and a distal portion of the guide wire separated including the tip.The separated portion was free floating in the patient anatomy and a non-abbott (sprinter) balloon dilatation catheter (bdc) was used to push the separated portion into a small branch of the obtuse marginal (om).An unspecified stent was then implanted to embed the separated portion in the om.An additional unspecified stent was implanted to treat the target lesion in the lcx.There was no adverse patient sequela and no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: 0.014 HI-TORQUE (HT) TURNTRAC GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7795539
• Report Number: 2024168-2018-06365
• Device Sequence Number: 11147123
• Product Code: DQX
• UDI-Device Identifier: 08717648222726
• UDI-Public: 08717648222726
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2018

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: 05/31/2020
• Device Catalogue Number: 1020014
• Device Lot Number: 8061361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR