MAUDE Adverse Event Report: ABBOTT VASCULAR HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING

Model Number	1005351H
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
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 the procedure was to implant a coronary sinus electrode.The electrode implant could not be advanced over the whisper guide wire.The decision was made to remove both the electrode and guide wire, but upon removal it was noted a portion of the guide wire was missing.The missing portion was retrieved when the coronary sinus introducer was removed.There were no reported adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned guide wire.The reported material separation was confirmed.The reported difficulty to advance was unable to be confirmed due to the guide wire separation.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 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 difficulty to advance and material separation appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement of the coronary sinus electrode over the guide wire, the guide wire became bent and/or kinked.Manipulation against resistance likely resulted in the reported core and polymer separation and subsequent damages to the guide wire.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9322668
• Report Number: 2024168-2019-13571
• Device Sequence Number: 16791379
• Product Code: DQX
• UDI-Device Identifier: 08717648037740
• UDI-Public: 08717648037740
• Combination Product (Y/N): N
• Initial Reporter Country: AA
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: 05/31/2020
• Device Model Number: 1005351H
• Device Catalogue Number: 1005351H
• Device Lot Number: 8061372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1