MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS PHD; HEMOSTASIS VALVE

Model Number 00884450160503

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

Patient Problem Air Embolism (1697)

Event Date 02/24/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a percutaneous coronary intervention [pci], air was accidentally injected into the patient's vasculature system.The physician had successfully acquired arterial access and had negotiated the patient's coronary artery under fluoroscopy with a guidewire and an interventional guide catheter.During the procedure, the physician was complaining about a hemostasis valve that was leaking fluid and continued to use the hemostasis device.During the procedure air was accidentally injected into the patient's coronary artery, ecg changes were noted and conformed that the patient was experiencing a myocardial infarction [mi] and the procedure was stopped to observe vital signs and hemodynamics.Acls and basic life supporting protocols were activated and successfully administered per hospital policy.Additional lifesaving interventions, techniques, and medications were required.

Manufacturer Narrative

The suspect device has been returned for evaluation.The device was examined visually and microscopically.Functional testing was performed.Upon completion of the inspection no issues were observed.No leaks observed during investigation and the unit met inspection criteria.The complaint could not be confirmed.No definitive root cause could be identified upon completion of the investigation.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: PHD
• Type of Device: HEMOSTASIS VALVE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• MDR Report Key: 11455227
• MDR Text Key: 238938871
• Report Number: 9616662-2021-00004
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00884450160503
• UDI-Public: 00884450160503
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00884450160503
• Device Catalogue Number: MAP802/A
• Device Lot Number: K1981251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER; GUIDEWIRE; GUIDE CATHETER; GUIDEWIRE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention