MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. FEMOSTOP¿ GOLD; CLAMP, VASCULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 07/26/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Following a diagnostic coronary angiogram procedure, a pseudoaneurysm occurred.Manual arterial compression was applied for 20 minutes and a femostop was placed for 3 to 4 hours, with cessation of arteriotomy bleeding.Discoloration and mild to moderate hematoma was noted and a bedside ultrasound was performed which revealed a pseudoaneurysm with continuous intramural bleeding.Vascular surgery was notified and patient was taken to surgery for repair.General anesthesia was administered, irrigation and debridement were performed to relieve the pseudoaneurysm followed by surgical repair of the vessel and subcutaneous thrombin material injection.There was no adverse patient sequela after surgical repair and no reported clinically significant delay in the coronary angiographic procedure or therapy.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Review of the device history record was not possible as the lot number is unknown.

• Brand Name: FEMOSTOP¿ GOLD
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 8949261
• MDR Text Key: 156093549
• Report Number: 2648612-2019-00067
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K110193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR