MAUDE Adverse Event Report: ABBOTT VASCULAR INC. HI-TORQUE WHISPER; WIRE, GUIDE, CATHETER

Model Number	1005357H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left circumflex coronary artery with 100% occlusion, moderate calcification and mild tortuosity.Through an unspecified 6 fr sheath, a 0.14 whisper guide wire (gw) and an unspecified 1.5x15mm dilatation catheter balloon were advanced.During removal of the balloon, the distal tip of the gw separated and was able to be retracted to the distal part of an unspecified 6fr guideliner.Then a 2.0 x 6m trek rx balloon dilation catheter was advanced alongside the gw to trap and remove the separated device.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.It was reported that during removal of the balloon over the guide wire, the guide wire tip separated.Analysis of the returned wire confirmed a core and polymer separation on the distal end.The core separation face was jagged, indicating the wire was subject to force.In this case, it is likely that the balloon catheter interacted with the wire during removal.Manipulation of the devices, when the interaction occurred, likely contributed to the reported material separation.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.

• Brand Name: HI-TORQUE WHISPER
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20301359
• Report Number: 2024168-2024-11260
• Device Sequence Number: 8783293
• Product Code: DQX
• UDI-Device Identifier: 08717648037801
• UDI-Public: (01)08717648037801(17)260331(10)4040471
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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: 03/31/2026
• Device Model Number: 1005357H
• Device Catalogue Number: 1005357H
• Device Lot Number: 4040471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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: 2.0X6MM TREK RX BALLOON; UNSPECIFIED 1.5X15MM BALLOON; UNSPECIFIED 6 FR SHEATH; UNSPECIFIED 6FR GUIDELINER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male