MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS PERIPHERAL BRAIDED CATHETER; Catheter, intravascular, diagnostic

Catalog Number 410038CB2/CN

Device Problem Crack (1135)

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

Event Date 05/30/2023

Event Type  Injury  

Event Description

Account alleges that during a tips procedure, the physician found the tip of the catheter was cracked during angiography.Then physician used a snare to catch the broken tips and pulled out from patient body.No additional injury on patient.

Manufacturer Narrative

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

• Brand Name: IMPRESS PERIPHERAL BRAIDED CATHETER
• Type of Device: Catheter, intravascular, diagnostic
• 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 bsn, rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 17080427
• MDR Text Key: 316745565
• Report Number: 3010665433-2023-00048
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450042373
• UDI-Public: 884450042373
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K053171
• 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
• Type of Report: Initial
• Report Date: 05/31/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 410038CB2/CN
• Device Lot Number: E2618549
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/07/2023
• Date Device Manufactured: 03/17/2023
• 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
• Patient Outcome(s): Required Intervention