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

Model Number C11165

Device Problems Deflation Problem (1149); Inflation Problem (1310); Device Displays Incorrect Message (2591)

Patient Problem Bradycardia (1751)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

During the procedure, the patient experienced bradycardia.When attempting to deflate the dome, no pressure or air would release.The digital manometer read 73 but the dome appeared fully inflated.The dome was manually pressed which deflated the dome.The dome was attempted to be re-inflated, but it would not easily re-inflate.Eventually the dome did re-inflate but the manometer still did not appear to be working correctly.The patient was bradycardic, atropine was administered but ineffective.Shortly after the air in the dome was released, the patient's heart rate returned to baseline.There was no patient harm.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9203875
• MDR Text Key: 162704959
• Report Number: 2648612-2019-00087
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 05414734050036
• UDI-Public: 05414734050036
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2020
• Device Model Number: C11165
• Device Lot Number: 6904963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2019
• 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: 79 YR
• Patient Weight: 97