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

Catalog Number	1000462HJ
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the hi-torque balance heavyweight hydro 014 guide wire was noted to have crumbling coating (teflon coating) during an unspecified procedure.It cannot be confirmed that no foreign material remains in the anatomy.No additional information was provided.
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the electronic lot history record, corrective action tracking system for the web (catsweb) database review, and similar incident query was not performed because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the subsequent patient effect appears to be related to operational context.It is unconfirmed if a portion or the teflon remains within the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE HEAVYWEIGHT 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: 18672804
• Report Number: 2024168-2024-01624
• Device Sequence Number: 17946118
• Product Code: DQX
• UDI-Device Identifier: 08717648015496
• UDI-Public: 08717648015496
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K021228
• 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
• Type of Report: Initial
• 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 Catalogue Number: 1000462HJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown