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

Catalog Number	1005357H
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned 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/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties or patient effect.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a distal circumflex artery lesion.A ht whisper guide wire was advanced and retracted with resistance noted with the impella device.The tip of the whisper guide wire sheared off in the circumflex artery during intervention.The physician determined the risk of perforation was too high therefore no attempts were made to snare the separated portion of the guide wire.The distal end of the guide wire remains embedded in the circumflex artery.Kissing balloons and another whisper guide wire were used to complete the procedure.There were no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
B5 - describe event or problem: updated.D9, h3: device returning update from no to yes.Attached: medwatch report #mw5153428.A visual inspection as performed on the returned device.The reported material separation was confirmed.The reported difficult to advance and remove could not be tested due to the device condition.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/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties or patient effect.The separation portion of the guide wire remains embedded in the lesion.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a distal circumflex artery lesion.A ht whisper guide wire was advanced and retracted with resistance noted with the impella device.The tip of the whisper guide wire sheared off in the circumflex artery during intervention.The physician determined the risk of perforation was too high therefore no attempts were made to snare the separated portion of the guide wire.The distal end of the guide wire remains embedded in the circumflex artery.Kissing balloons and another whisper guidewire were used to complete the procedure.There were no adverse patient sequela and there was no clinically significant delay in the procedure.No additional information was provided.Medwatch report #mw5153428 states: impella insertion and removal procedure; intervention guide wire broke-off during removal from distal circumflex branch but was not causing issues; therefore, did not attempt to retrieve.Whisper ms 0.014".

• Brand Name: HI-TORQUE WHISPER GUIDE WIRES
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18727335
• Report Number: 2024168-2024-01925
• Device Sequence Number: 6235267
• Product Code: DQX
• UDI-Device Identifier: 08717648037801
• UDI-Public: (01)08717648037801(17)250430(10)3053171
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: 04/30/2025
• Device Catalogue Number: 1005357H
• Device Lot Number: 3053171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMPELLA DEVICE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 104 KG