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

Catalog Number	1011834H
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Pericardial Effusion (3271)
Date of Event	10/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch mw5147741 received which states: patient with chronic systolic heart fail lbbb (left bundle branch block) ef (ejection fraction) 30-35% ef underwent a biv (biventricular) ventricular defibrillator.During the procedure the distal tip of the whisper wire dislodged in the aiv (anterior interventricular vein)/high lateral trivary region.The distal tip sheared off.Multiple attempts made to snare the distal tip of the wire of different mm 4-7 and 10.Unfortunately unsuccessful without success.Small pericardial effusion noted.Subsequent to the receipt of the medwatch, it was reported that the tip remains in the patient and the pericardial effusion was small and was only monitored.The patient was hospitalized one day for monitoring and then they were stable and discharged.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Attachment: medwatch report #mw5147741.
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 determined the reported difficulties, in addition to, the treatment and patient effects appear to be related to the operational context of the procedure.The separated portion of the wire remains within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9/h3: return status updated from yes to no.H6: medical device problem code 1212 was removed and 1528, 2920 were added.
Event or Problem Description
Received medwatch mw5147741 which states: patient with chronic systolic heart fail lbbb (left bundle branch block) ef (ejection fraction) 30-35% ef underwent a biv (biventricular) ventricular defibrillator.During the procedure the distal tip of the whisper wire dislodged in the aiv (anterior interventricular vein)/high lateral trivary region.The distal tip sheared off.Multiple attempts made to snare the distal tip of the wire of different mm 4-7 and 10.Unfortunately unsuccessful without success.Small pericardial effusion noted.Subsequent to the receipt of the medwatch, it was reported that the tip remains in the patient and the pericardial effusion was small and was only monitored.The patient was hospitalized one day for monitoring and then they were stable and discharged.Subsequent to the initially filed report, it was reported that there was resistance with the anatomy during advancement but more with withdrawal.The vessel was tortuous.No additional information was provided.

• 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: 18440621
• Report Number: 2024168-2024-00134
• Device Sequence Number: 20778561
• Product Code: DQX
• UDI-Device Identifier: 08717648116100
• UDI-Public: 08717648116100
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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: 1011834H
• Device Lot Number: 3052571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 61 KG