MAUDE Adverse Event Report: BRIVANT LIMITED 0.014" SHEPHERD ES GUIDEWIRE - STRAIGHT 300 CM - 4 GMS

Model Number 901068-02

Device Problems Flaked (1246); Peeled/Delaminated (1454); Mechanical Jam (2983)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/25/2022

Event Type  malfunction  

Manufacturer Narrative

Complaint investigation underway and will be attached to this report.

Event Description

The physician introduced a shepherd guide wire and jade balloon to angioplasty a segment of the anterior tibial artery (at).After deflation, the physician attempted to walk the balloon distally to treat the next diseased segment but resistance was experienced and the balloon would not cross.The physician attempted to push and pull the guide wire, however, resistance was felt when the guide wire was pulled back.Under fluoroscopy, the physician removed the guide wire and balloon together.The polymer coating of the guide wire was observed to be stripped and bunched, which prevented the balloon to be pushed distally.The physician used a non-csi guide wire to deliver the balloon catheter distally and finish the angioplasty.

Event Description

The physician introduced a shepherd guide wire and jade balloon to angioplasty a segment of the anterior tibial artery (at).After deflation, the physician attempted to walk the balloon distally to treat the next diseased segment but resistance was experienced and the balloon would not cross.The physician attempted to push and pull the guide wire, however, resistance was felt when the guide wire was pulled back.Under fluoroscopy, the physician removed the guide wire and balloon together.The polymer coating of the guide wire was observed to be stripped and bunched, which prevented the balloon to be pushed distally.The physician used a non-csi guide wire to deliver the balloon catheter distally and finish the angioplasty.

Manufacturer Narrative

Complaint investigation underway and will be attached to this report.

• Brand Name: 0.014" SHEPHERD ES GUIDEWIRE - STRAIGHT 300 CM - 4 GMS
• Type of Device: 0.014" SHEPHERD ES GUIDEWIRE - STRAIGHT 300 CM - 4 GMS
• Manufacturer (Section D): BRIVANT LIMITED; parkmore west business park; galway, H91CK 22; EI H91CK22
• Manufacturer (Section G): BRIVANT LIMITED; parkmore west business park; galway, H91CK 22; EI H91CK22
• Manufacturer Contact: krishna priya kodumadu venkittaraman ; parkmore west business park; galway, H91CK-22 ; EI H91CK22
• MDR Report Key: 15455206
• MDR Text Key: 304729914
• Report Number: 3006010712-2022-00040
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 10850026568544
• UDI-Public: 10850026568544
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120137
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

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
• Device Operator: Health Professional
• Device Model Number: 901068-02
• Device Catalogue Number: 7-10096-02
• Device Lot Number: 7211880
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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 Age: 87 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White