MAUDE Adverse Event Report: TERUMO MEDICAL CORP. ANGIO-SEAL; DEVICE, HEMOSTASIS, VASCULAR

Lot Number 06086709

Device Problem Device Slipped (1584)

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

Event Date 08/13/2018

Event Type  malfunction  

Event Description

Angioseal device was inserted and deployment attempted in usual manner.Upon pulling the device back to advance tube to tamp collagen down, the entire device came out with nothing attached at the end.The collagen plug can be seen attached to the string, stuck in device.

• Brand Name: ANGIO-SEAL
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORP.; 265 davidson avenue ste. 320; somerset NJ 08873
• MDR Report Key: 7951222
• MDR Text Key: 123213327
• Report Number: 7951222
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 06086709
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31390 DA