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

Model Number	C11165
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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: 9203875
• Report Number: 2648612-2019-00087
• Device Sequence Number: 3396262
• Product Code: DXC
• UDI-Device Identifier: 05414734050036
• UDI-Public: 05414734050036
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K110193
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2020
• Device Model Number: C11165
• Device Lot Number: 6904963
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 97