MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WHISPER LS GUIDE WIRE

Model Number	1005351H
Medical Device Problem Codes	Product Quality Problem (1506); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the mildly calcified, moderately tortuous, 90% stenosed mid right coronary artery.While using a whisper ls guide wire, the tip of the wire was unable to be manipulated due to thermal sagging [separation].An unspecified guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo lesion in the mildly calcified, moderately tortuous, 90% stenosed mid right coronary artery.While using a whisper ls guide wire, the tip of the wire was unable to be manipulated due to thermal sagging [separation].An unspecified guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was received: the reported thermal sagging was a lack of support as the tip of the guide wire was too soft or flexible.No additional information was provided.
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.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 materials too soft, flexible appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement through the mildly calcified, moderately tortuous, 90% stenosed anatomy, the guide wire tip kinked resulting in the thermal sagging or support issues.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: medical device problem code 1506 was removed.

• Brand Name: HI-TORQUE WHISPER LS GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11267667
• Report Number: 2024168-2021-00796
• Device Sequence Number: 10951046
• Product Code: DQX
• UDI-Device Identifier: 08717648037740
• UDI-Public: 08717648037740
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: 07/31/2022
• Device Model Number: 1005351H
• Device Catalogue Number: 1005351H
• Device Lot Number: 0082171
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1