MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE CONNECT GUIDE WIRE

Model Number	1012595
Medical Device Problem Codes	Break (1069); Stretched (1601); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this was a procedure to treat a right common iliac artery with chronic total occlusion.A retrograde approached was to be performed.An ht connect 250t guidewire (gw) was advancing, but could not cross the target lesion due to anatomical challenges.Then, approximately 5cm from the distal tip, a core break was observed.The coils seemed to have unraveled.Therefore, the gw was removed intact.The procedure was completed with an unspecified gw and a different approach.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was returned.As per the lot history review it was concluded that the guidewires were manufactured according to the specification.The required test and inspections were performed and passed.Based on the information provided above, the cause of the failure cannot be traced to the device as adverse event is related to the patient condition.There is no evidence to suggest that the design of the guidewire or any manufacturing related concerns has contributed to the incident.It is therefore likely that the guidewire fractured after being challenged beyond its design capabilities in the challenging patient¿s anatomy during the procedure.Scanning electron microscopy (sem) was performed and the analysis confirmed that the fracture occurred due to torsional overloading of the guidewire.Integer has not implemented any corrections as a result of this complaint.
Event or Problem Description
N/a.

• Brand Name: HI-TORQUE CONNECT GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): LAKE REGION MEDICAL INTL RESEA
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12689181
• Report Number: 2024168-2021-09557
• Device Sequence Number: 14514429
• Product Code: DQX
• UDI-Device Identifier: 08717648175053
• UDI-Public: 08717648175053
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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,Followup
• Report Date (Section B): 06/02/2022

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: 03/31/2023
• Device Model Number: 1012595
• Device Catalogue Number: 1012595
• Device Lot Number: 5771227
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2020
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 82 KG