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

Model Number	1010485-H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that before opening, the package of the pilot guide wire was noted to have a separated piece of wire inside the package.The device was not opened or used and there was no patient involvement.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspection was performed on the returned device.The reported material separation was confirmed as a contamination.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.Fourier transform infrared spectroscopy (ftir) was performed on the material found in the sealed pouch.The analysis concluded that the material was likely polymer.Based on this evaluation, a potential product quality issue has been identified.The potential product quality issue and corrective action, if any, will be determined per internal operating procedures, the exception management process.

• Brand Name: HI-TORQUE PILOT
• 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: 19548599
• Report Number: 2024168-2024-07263
• Device Sequence Number: 17820428
• Product Code: DQX
• UDI-Device Identifier: 08717648073953
• UDI-Public: (01)08717648073953(17)260228(10)4031271
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 02/28/2026
• Device Model Number: 1010485-H
• Device Catalogue Number: 1010485-H
• Device Lot Number: 4031271
• 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: 05/23/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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
• Patient Sex: Unknown