MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Catalog Number 1013319J

Device Problems Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/13/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.Additionally, the separated portion of the distal tip remains free floating in the artery.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Event Description

It was reported that the procedure was to treat the left anterior descending (lad) and diagonal coronary artery bifurcation with high calcification.The versaturn guide wire was placed in the diagonal artery and a non-abbott guide wire was placed in the lad.A non-compliant balloon was used due to the high calcification and then a stent was then implanted in the lad.This trapped the versaturn guide wire and the distal tip separated and the wire unraveled.The distal tip remains free floating in the artery and no dilatation of the diagonal artery was able to be performed.The patient was doing well at the end of the procedure.No additional information was provided.

• Brand Name: HT VERSATURN GUIDE WIRE
• Type of Device: 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: 18267910
• MDR Text Key: 329738309
• Report Number: 2024168-2023-13481
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013319J
• Device Lot Number: 3091471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDE 7F MACH CLS 3.5; SION BLUE GUIDE WIRE
• Patient Outcome(s): Other