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

Catalog Number	410038CB2/CN
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3010665433-2023-00048
• Device Sequence Number: 11309640
• Product Code: DQO
• UDI-Device Identifier: 00884450042373
• UDI-Public: 884450042373
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2026
• Device Catalogue Number: 410038CB2/CN
• Device Lot Number: E2618549
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/07/2023
• Date Device Manufactured: 03/17/2023
• 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