MAUDE Adverse Event Report: ABBOTT VASCULAR GUIDE WIRE

Catalog Number UNKNOWN BMW GUIDE WIRE

Device Problem Material Separation (1562)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 10/31/2023

Event Type  Injury  

Event Description

It was reported that the procedure was to treat the right coronary artery via right radial access.A sheath was placed and a brachial loop was found.The access site was switched to the left radial and the procedure was completed.The patient returned due to pain in the right arm on (b)(6) 2023 and reportedly on (b)(6) 2024 the patient removed a 30-40 cm piece of wire from their knuckle themselves.X-ray and computed tomography (ct) scan shows radiopaque straight linear foreign body within the right antecubital fossa and further curvilinear foreign body at the right thoracic apex, within the right subclavian artery.There is the potential that the guide wire is an unspecified balance middleweight guide wire.The patient is doing alright and was discharged home without any additional treatment.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

• Brand Name: 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: 18987378
• MDR Text Key: 338721265
• Report Number: 2024168-2024-03748
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103101
• 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: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN BMW GUIDE WIRE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• 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): Hospitalization