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

Catalog Number	1011835H
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	10/02/2019
Type of Reportable Event	Serious Injury
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.The device was received.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 to treat a heavily calcified common femoral artery that did not have any tortuosity.A 300 cm whisper es guide wire was used; however, it initially met resistance with the anatomy.Then during removal, the guide wire became separated.One portion was in the aorta and the other was in the common femoral artery.Therefore, two snare devices were used to remove the components.An unspecified whisper guide wire was then used to complete the procedure.There was no adverse patient sequela reported.There was a clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Additional information was received.The tip of the whisper guide wire was the area where the separation had occurred.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult 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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.The noted scrapped teflon coating likely occurred due to interaction with the torque device being tight against the guide wire.The noted multiple bends on the core likely occurred due to handling or 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: 9244754
• Report Number: 2024168-2019-12969
• Device Sequence Number: 14090868
• Product Code: DQX
• UDI-Device Identifier: 08717648116117
• UDI-Public: 08717648116117
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 1011835H
• Device Lot Number: 9050771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention