MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING PERFORMA®.NON-BRAIDED; PERIPHERAL CATHETERS

Catalog Number 7757-2MP80

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2021

Event Type  malfunction  

Event Description

The account alleges that after removing the catheter form the femoral artery of a pediatric congenital heart defect patient, post pda occlusion procedure, the tip of the catheter detached outside the patient's anatomy.No medical or interventional procedure deemed necessary.A new catheter was used to successfully complete this procedure.No patient injury to report.

Manufacturer Narrative

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

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be 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: PERFORMA®.NON-BRAIDED
• Type of Device: PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr; houston TX 77047
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 13050106
• MDR Text Key: 285643434
• Report Number: 3010665433-2021-00124
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450356593
• UDI-Public: 884450356593
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K943739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: 7757-2MP80
• Device Lot Number: E2061878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 05/23/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMPLANTABLE ARTERIAL CLOSURE DEVICE.; INTERVENTIONAL GUIDEWIRE.