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

Model Number	00884450160503
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: HEMOSTASIS VALVE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; parkmore business park west; ballybrit, galway ; EI
• MDR Report Key: 11455227
• Report Number: 9616662-2021-00004
• Device Sequence Number: 3523947
• Product Code: DTL
• UDI-Device Identifier: 00884450160503
• UDI-Public: 00884450160503
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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 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
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER; GUIDEWIRE; GUIDE CATHETER; GUIDEWIRE
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention