MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD PERICARDIOCENTESIS CATHETER; IRRIGATION CATHETER

Catalog Number	PC803EU/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The account alleges that during an emergent pericardiocentesis procedure, the access guidewire coil started to unravel.The patient was hemodynamically unstable and diagnosed with cardiac tamponade at the time.The access wire was discarded, and a new kit was opened and used to complete this procedure for the patient.
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.A photograph was provided by the account.The complaint is confirmed based on the photo received from the account.A root cause could not be conclusively determined.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.Should the device be returned later, the investigation will be re-opened.

• Brand Name: PERICARDIOCENTESIS CATHETER
• Common Device Name: IRRIGATION CATHETER
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• Manufacturer (Section G): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 14641293
• Report Number: 9616662-2022-00006
• Device Sequence Number: 4867954
• Product Code: GBX
• UDI-Device Identifier: 00884450013465
• UDI-Public: 884450013465
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: 05/31/2024
• Device Catalogue Number: PC803EU/A
• Device Lot Number: K2319605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown