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

Model Number	901068-02
Medical Device Problem Codes	Flaked (1246); Peeled/Delaminated (1454); Mechanical Jam (2983)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.
Event or Problem 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 or Problem 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.
Additional Manufacturer Narrative
Complaint investigation underway and will be attached to this report.

• Brand Name: 0.014" SHEPHERD ES GUIDEWIRE - STRAIGHT 300 CM - 4 GMS
• Common Device Name: 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
• Report Number: 3006010712-2022-00040
• Device Sequence Number: 6842602
• Product Code: DQX
• UDI-Device Identifier: 10850026568544
• UDI-Public: 10850026568544
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K120137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 901068-02
• Device Catalogue Number: 7-10096-02
• Device Lot Number: 7211880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/30/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/20/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White