MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO .IMPRESS®.BRAIDED CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 56538CB2/B

Device Problems Fracture (1260); Material Separation (1562)

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

Event Date 04/18/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The account alleges that during a percutaneous transluminal angioplasty [pta] procedure within the patient's periphery, a catheter tip detached.The physician had acquired right retrograde popliteal artery access and had negotiated the patient's contralateral left ilio-femoral conduit with an interventional guidewire and a 5f catheter.During catheter manipulations under fluoroscopy the catheter tip detached but remained on the guidewire.The detached catheter tip was removed along with the guidewire.No additional medical intervention was deemed necessary.A new device was used to complete this procedure.No additional patient consequences to report.

Manufacturer Narrative

The suspect medical device has been returned for evaluation.The device was visually and microscopically evaluated.The complaint is confirmed.The root cause can be contributed to the manufacturing process.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.Corrective actions are in progress.

• Brand Name: .IMPRESS®.BRAIDED CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego, CA 92154
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 16811832
• MDR Text Key: 313996692
• Report Number: 3011642792-2023-00028
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450035955
• UDI-Public: 884450035955
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 56538CB2/B
• Device Lot Number: I2516670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• 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: INTERVENTIONAL GUIDEWIRE.