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

Catalog Number	1020014
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event has been estimated exemption number e2019001- permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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.Estimated dates: na.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified left anterior descending artery.The 014 turntrac guide wire was jailed behind an unspecified stent.Resistance was felt with the stent during withdrawal.After removal it was noted that the coils were stretched and possibly fractured.The procedure was complete at that point.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Date of event has been estimated.A visual and dimensional inspection was performed on the returned guide wire.The reported guide wire stretched coils were confirmed.The reported separation was unable to be confirmed as there were no separation noted in the guide wire.The reported difficult to remove was unable to be confirmed or replicated in a testing environment as it was 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 and or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the reported information, the 014 high torque turntrac guide wire was jailed behind an unspecified stent resulting in the reported difficulty to remove during retraction.Manipulation of the guide wire during retraction likely caused the stretched coils and the appearance of a separation.The noted teflon coating damage was likely caused during retraction by the torque device used in the procedure.The noted bends on the core likely occurred post procedure or during packing for return analysis.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified left anterior descending artery.The 014 turntrac guide wire was jailed behind an unspecified stent.Resistance was felt with the stent during withdrawal.After removal it was noted that the coils were stretched and possibly fractured.The procedure was complete at that point.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HT TURNTRAC
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8871718
• Report Number: 2024168-2019-10663
• Device Sequence Number: 3079395
• 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): 11/06/2019

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: 11/30/2020
• Device Catalogue Number: 1020014
• Device Lot Number: 8121261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1