MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS PERIPHERAL CATHETER

Catalog Number 510038BER

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The account alleges that during an endovascular aortic aneurysm repair procedure, a catheter tip detached within the patient.The physician had acquired retrograde femoral artery access.During catheter manipulations over a stiff guidewire, the catheter kinked and detached within the patient's ipsilateral common iliac artery.The physician was able to successfully remove the catheter tip from the patient with a vascular snare device.No additional patient consequences to report.

Manufacturer Narrative

The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.No definitive root cause could be determined however, it is likely that significant force was applied to the device during use.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 found.

• Brand Name: IMPRESS PERIPHERAL CATHETER
• Type of Device: PERIPHERAL CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston, TX 77047
• Manufacturer Contact: david lockridge ; 1600 merit parkway; south jordan, UT 84095 ; 8012084551
• MDR Report Key: 9266964
• MDR Text Key: 164666801
• Report Number: 3010665433-2019-00071
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450011485
• UDI-Public: 00884450011485
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 510038BER
• Device Lot Number: E1600006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention