MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, B.V. ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE; DEVICE, HEMOSTASIS, VASCULAR

Model Number 610130

Device Problems Device Slipped (1584); Component Missing (2306); Mechanical Jam (2983)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/04/2015

Event Type  Injury  

Event Description

A 6f angio-seal vip came out of a patient following deployment and bleeding followed.It was reported the collagen may have been stuck on the suture and entire closure device came back out.The patient went to operating room.The angio-seal device could not be located.The patient was fine following surgery.

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.The angio-seal device instructions for use (ifu) state that bleeding or a hematoma at the puncture site are a possible risk or situation that may be associated with the use of the device or vascular access procedures.If this should occur, the ifu instructs the user to apply digital or manual pressure to the puncture site and if necessary, monitor pedal pulses.The angio-seal device instructions for use (ifu) states that if the angio-seal device does not anchor in the artery due to improper orientation of the anchor or patient vascular anatomy, the entire absorbable components and delivery system should be withdrawn from the patient.Hemostasis can be achieved by applying manual pressure.

• Brand Name: ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, B.V.; lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, B.V.; lot 21; caguas west industrial park; caguas, puerto rico 00726 -099
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 5126929
• MDR Text Key: 27444328
• Report Number: 3003681312-2015-00093
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: 610130
• Device Catalogue Number: 610130
• Device Lot Number: 5139137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention