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

Catalog Number 46535RIM

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

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

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a percutaneous transluminal peripheral intervention, the catheter tip detached within the patient.The physician had acquired ipsilateral retrograde femoral artery access and had negotiated the patient's common iliac bifurcation with a guide-wire and 4f catheter.During catheter withdraw from the sheath is was noted that the catheter tip had detached yet remained on the guide-wire within the patient's aortic bifurcation.The physician up-sized the sheath to 7f and noted some calcification in the patient's vasculature that may have contributed to the tip detachment during catheter removal.The guide wire and the catheter tip were both successfully removed with no additional consequences to the patient.

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: 9371266
• MDR Text Key: 168821795
• Report Number: 3010665433-2019-00074
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450200018
• UDI-Public: 00884450200018
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

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 Expiration Date: 06/30/2022
• Device Catalogue Number: 46535RIM
• Device Lot Number: E1627242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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