MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PREMIUM SURGICLIP III; CLIP, IMPLANTABLE

Model Number 133650

Device Problems Mechanical Problem (1384); Device Slipped (1584); Material Deformation (2976)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/14/2022

Event Type  Injury  

Event Description

According to the reporter, during carotid endarterectomy, some clips fell out of the applicator before being applied, others crossed branches while some did not adjust the closure.The case was continued using a suture.Postoperatively, just before extubation, one of the clips applied to facial branch of the left internal jugular vein jumped out of the blood vessel, causing massive bleeding through the drainage.The patient was re-operated on emergently to control bleeding.Two new clips were placed.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PREMIUM SURGICLIP III
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14847238
• MDR Text Key: 294948442
• Report Number: 2647580-2022-02219
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10884521517394
• UDI-Public: 10884521517394
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K142869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 133650
• Device Catalogue Number: 133650
• Device Lot Number: P2A0290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 06/28/2022
• Date Device Manufactured: 01/13/2022
• 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 Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 90 KG