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

Model Number	1005351H
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
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 an unspecified balloon catheter was being backloaded on to a 014 whisper ls guide wire; however, they became stuck.The balloon catheter and guide wire had to be removed as a unit.The procedure was successfully completed with a new whisper ls guide wire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional and functional inspections were performed on the returned device.The reported difficulty to advance and remove the guide wire from a balloon catheter were unable to be confirmed as the guide wire was able to advance and retract without any resistance noted.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.Factors that may contribute to the inability to advance/position the guide wire and cause resistance between the devices may include, but not limited to, device placement technique, anatomical conditions, device support, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, condition of balloon catheter, coagulation of blood and/or procedural contaminates.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 was unable to determine a conclusive cause for the reported difficulty to advance and remove.However, the noted damages to the coils and teflon appear to be related to operational circumstances of the procedure and likely occurred during packing for return analysis.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: 9338896
• Report Number: 2024168-2019-13718
• Device Sequence Number: 19300873
• Product Code: DQX
• UDI-Device Identifier: 08717648037740
• UDI-Public: 08717648037740
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 02/10/2020

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: 01/31/2020
• Device Model Number: 1005351H
• Device Catalogue Number: 1005351H
• Device Lot Number: 8022071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 02/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1