MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. RICHMOND PERICARDIOCENTESIS KIT; CATHETER

Model Number	00884450015278
Medical Device Problem Codes	Material Fragmentation (1261); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/24/2020
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 an emergent pericardial drainage procedure for a cardiac tamponade the tip of the catheter got detached during the withdrawal.The tip remained in the patient's body.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.No definitive root cause could be determined however, it is likely that significant force was applied to the device during use.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: PERICARDIOCENTESIS KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC. RICHMOND; 12701 kingston ave; chester VA 23836
• MDR Report Key: 10928922
• Report Number: 1125782-2020-00027
• Device Sequence Number: 982032
• Product Code: GBX
• UDI-Device Identifier: 00884450015278
• UDI-Public: 00884450015278
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 00884450015278
• Device Catalogue Number: PC101/JPB
• Device Lot Number: T1825553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 03/29/2021
• 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