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

Model Number	1020013
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Device Difficult to Setup or Prepare (1487); Failure to Advance (2524)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.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 during preparation and before use in the patient, when the doctor was trying to shape the tip of hi-torque turntrac guide wire, it was difficult to shape the tip and the outer layer was detached from the inner layer during the shaping process.The device was not used and there was no patient involvement.Another guide wire was used to complete the procedure with no clinically significant delay and no adverse patient effects.No additional information was provided.
Event or Problem Description
Subsequent to the initial 30-day medwatch report, the following information was received: after a failed attempt to cross the mid left anterior descending coronary artery that was heavily tortuous and moderately calcified, the device was removed for reshaping.During the reshaping process, the guidewire remained in one piece, but the core detached.The device was not used again.No additional information was provided.
Additional Manufacturer Narrative
A visual, dimensional and functional inspection was performed on the returned guide wire.The reported break was unable to be confirmed as the device was stretched, without a core break.The reported difficulty to set up/shape the tip and failure to advance was unable to be 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 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 core break, difficulty to set up and failure to advance appear to be related to operational circumstances of the procedure.Based on the reported information, after a failed attempt to cross the heavily tortuous and moderately calcified anatomy, it is likely that during retraction the coils became stretched and wavy causing the appearance of a break and the difficulty to reshape the tip.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.H6: patient code 2645-removed h6: device code 1454-removed.

• Brand Name: HT TURNTRAC
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9462749
• Report Number: 2024168-2019-14489
• Device Sequence Number: 3066832
• Product Code: DQX
• UDI-Device Identifier: 08717648222702
• UDI-Public: 08717648222702
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 02/26/2020

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: 01/31/2021
• Device Model Number: 1020013
• Device Catalogue Number: 1020013
• Device Lot Number: 9022761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2019
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR