MAUDE Adverse Event Report: ABBOTT VASCULAR UNKNOWN AV GUIDE WIRE

Catalog Number UNKNOWN BMW GUIDE WIRE

Device Problem Material Separation (1562)

Patient Problems Hematoma (1884); Pain (1994); Vasoconstriction (2126); Foreign Body In Patient (2687)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Date of event has been estimated.

Event Description

It was reported that the procedure was performed approximately 3 months ago to treat an unspecified lesion.During advancement of the balance middleweight guide wire, the patient¿s arm began to spasm.During removal, the guide wire separated.The distal portion was left in the patient.Three months after the procedure the patient is experiencing pain in the arm.An x-ray was done, and it was noted that something unusual was visible in the arm [the separated guidewire].No additional information was provided.

Event Description

Additional information was received: the initial procedure date was (b)(6) 2019.The x-ray was done on (b)(6) 2020.The lesion being treated was the right radial artery trying to advance through tortuous small vessels, moderate calcification.After removal of the wire, a hematoma developed rapidly.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record and complaint history could not be conducted because the lot number was not provided.In the absence of device returned for analysis, a conclusive cause for the reported guide wire core detachment could not be determined.The patient effect of foreign body in patient is related to procedure circumstance.A conclusive cause for the reported patient effects of vasoconstriction and pain, and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The udi is unknown because the part and lot #s were not provided.

• Brand Name: UNKNOWN AV GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9801336
• MDR Text Key: 183891242
• Report Number: 2024168-2020-02091
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K103101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• 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
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention