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

Model Number	1000462HJ
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a lesion in right iliac artery.During the procedure, the distal portion of the hi-torque 014 bhw hydro 190cm guidewire (gw) broke in the chest / abdomen of the patient and was successfully snared and retrieved.The patient was admitted for additional observation.There was no adverse patient sequela.User facility medwatch (b)(4) report received that states "wire breakage in the chest and abdomen retrieved using foreign body retrieval device.Finally attempt to recanalization of the superior vena cava was unsuccessful.Attempt to recanalized the right subclavian vein to these superior vena cava was unsuccessful.Right upper extremity midline placement 20 cm length with the tip in the superior vena cava." no additional information was provided.
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Attachment: user facility medwatch (b)(4) report.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the lot number was not provided.As there was no reported damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the anatomy/other devices and/or inadvertent mishandling resulted in the reported material separation.The treatment appears to be related to the operational context of the procedure as the separated portion was successfully snared and retrieved.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: 15757208
• Report Number: 2024168-2022-11402
• Device Sequence Number: 20393130
• Product Code: DQX
• UDI-Device Identifier: 08717648015496
• UDI-Public: 08717648015496
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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 Model Number: 1000462HJ
• Device Catalogue Number: 1000462HJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/12/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 39 KG