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

Catalog Number UNK BMW ELITE

Device Problem Material Separation (1562)

Patient Problems Headache (1880); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Embolism/Embolus (4438)

Event Date 06/14/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.D4: the udi number is not known as the part and lot number were not provided.

Event Description

It was reported that on (b)(6) 2023 , the procedure was performed to treat a 70% stenosed lesion in the left circumflex (lcx) artery.The bmw elite guidewire (gw) was used in the procedure; however, the tip of the gw broke in the patient.A stent was implanted to embed the separated tip of the gw.A month after the procedure, the patient experienced a headache and sought treatment.It was found that the tip of the gw had migrated to the intracranial blood vessels of the patient.Neurological surgery was performed to remove the tip of the gw from the patient.No additional information was provided.

Manufacturer Narrative

The incident information was reviewed; however, the product was not returned for analysis.The device history record (dhr) and exception review was performed and revealed no indication of a product quality issue.A review of the electronic lot history record and similar complaint query was not performed because the part/lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported material separation; however, the subsequent patient effects and treatments appear to be related to the operational context of the procedure.Factors that may contribute to tip separation during use include, but are not limited to, interaction with accessory devices, interaction with the patient¿s anatomy, damage incurred during preparation, or excessive force.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported tip separation.The reported patient effect of embolism is listed in the hi torque guide wires instructions for use as a known patient effect(s) of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRES
• 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: 18983424
• MDR Text Key: 338658414
• Report Number: 2024168-2024-03705
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK BMW ELITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention; Hospitalization