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

Model Number	1011834H
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The xience skypoint stent system referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was performed to treat a target lesion in the moderately tortuous right coronary artery (rca).The 4.0 x 18 mm xience skypoint stent delivery system was advanced over the whisper extra support guide wire.Resistance was noted during advancement, and the stent delivery system became stuck.The stent delivery system could not be removed from the guide wire.Both devices were removed as a single unit.There was no adverse patient effect and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported difficult to advance and the reported difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.Additionally, it was noted that the device had torn polymer coating and teflon coating scrapping.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.There was no damage noted to the device 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 difficulties appear to be related to circumstances of the procedure as it is likely that that a buildup of blood and/or contrast on the guide wire and/or interaction/damages to the xience skypoint stent delivery system contributed to the reported difficult to advance and the reported difficult to remove.Interaction and/or manipulation of the device resulted in the noted device damages (torn polymer coating, teflon coating scrapping).There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI-TORQUE WHISPER ES GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12363049
• Report Number: 2024168-2021-07480
• Device Sequence Number: 3821602
• Product Code: DQX
• UDI-Device Identifier: 08717648116100
• UDI-Public: 08717648116100
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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: 05/31/2023
• Device Model Number: 1011834H
• Device Catalogue Number: 1011834H
• Device Lot Number: 1062171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.0 X 18 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM