MAUDE Adverse Event Report: ABBOTT VASCULAR STARCLOSE VASCULAR CLOSURE SYSTEM; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number 14679-01

Device Problems Break (1069); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2016

Event Type  malfunction  

Event Description

The delivery shaft broke upon deployment.We had bilateral groins that needed the starclose.Two packages were opened and not sure which lot number is associated with the device that malfunctioned manufacturer response for starclose vascular closure system, (brand not provided) (per site reporter): they are sending me shipping material.

• Brand Name: STARCLOSE VASCULAR CLOSURE SYSTEM
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ABBOTT VASCULAR; 3200 lakeside drive; santa clara CA 95054
• MDR Report Key: 5839447
• MDR Text Key: 50914989
• Report Number: 5839447
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 14679-01
• Device Lot Number: 5121541
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/18/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR