MAUDE Adverse Event Report: MERIT MEDICAL MANUFACTURING IMPRESS®.BRAIDED CATHETER; PERIPHERAL CATHETERS

Catalog Number	46535RIM
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The account alleges that during a percutaneous transluminal angioplasty procedure [pta], the 4f catheter tip detached within the patient.The physician had acquired retrograde right femoral artery access and had negotiated the patient's ilio-femoral conduit with a super stiff.035 guidewire and 4f catheter.During over-the-wire catheter manipulations under fluoroscopy within the patient's common iliac artery, the catheter tip detached.The clinician acquired bilateral femoral access and successfully used a vascular snare device to externalize the foreign body from the patient liberating the iliac vessel.An additional catheter was used to complete this procedure.The patient was transferred post-procedure to icu for observation.Prolongation of hospitalization was required.The patient tolerated the procedure well with no additional consequences to report.
Additional Manufacturer Narrative
The suspect medical device was returned for evaluation.The device was visually and microscopically investigated.The complaint is confirmed.The root cause could not be determined however, it is likely that significant force was applied to the device during clinical use.The device history record was reviewed, and one exception document was identified.A search of the complaint database was performed and one similar complaint for this lot number was identified.

• Brand Name: IMPRESS®.BRAIDED CATHETER
• Common Device Name: PERIPHERAL CATHETERS
• Manufacturer (Section D): MERIT MEDICAL MANUFACTURING; 14646 kirby dr,; pearland TX 77047
• Manufacturer (Section G): MERIT MEDICAL MANUFACTURING; 14646 kirby dr,; pearland TX 77047
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18222055
• Report Number: 3010665433-2023-00096
• Device Sequence Number: 20280730
• Product Code: DQO
• UDI-Device Identifier: 00884450038109
• UDI-Public: 884450038109
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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: 05/31/2025
• Device Catalogue Number: 46535RIM
• Device Lot Number: E2436260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 11/28/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STIFF AMPLATZ GUIDEWRIE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown