MAUDE Adverse Event Report: ABBOTT VASCULAR 014 HT TURNTRAC GUIDE WIRE

Model Number	1020014
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a moderately torutous and dissected lesion in the mid right coronary artery.A 014 ht turntrac guide wire was advanced; however, there was a break in the coils around 20cm from the tip.An unspecified balloon catheter was advanced, but it was catching the coil at the break point and pushed the coils towards the tip of the wire.The coils only slid forwards by a few centimeters.The balloon couldn¿t get past the break point.The procedure was successfully completed by exchanging the wire with an unspecified guide wire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection were performed on the returned guide wire.The reported break was unable to be confirmed.The reported difficult to advance/position was unable to be confirmed due to the coil damage.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 similar incidents reported from this lot.The investigation determined the reported difficulty to advance/position and tip break appear to be related to operational circumstances of the procedure.Based on the returned analysis and reported information, it is likely that during tip shape process the coils were inadvertently stretched causing the appearance of a break and the difficulty to advance the balloon catheter over the guide wire.The noted wavy coils, kinks and bends on the guide wire likely occurred during packing for returned analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: 014 HT TURNTRAC GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9678293
• Report Number: 2024168-2020-01263
• Device Sequence Number: 3444917
• Product Code: DQX
• UDI-Device Identifier: 08717648222726
• UDI-Public: 08717648222726
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K173795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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: 07/31/2021
• Device Model Number: 1020014
• Device Catalogue Number: 1020014
• Device Lot Number: 9082061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1