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

Catalog Number 56535RIM

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

Patient Problem No Information (3190)

Event Date 09/16/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect device was not returned for evaluation however a photo was provided and reviewed.The complaint was confirmed.The root cause was undetermined however the photo shows evidence that the tip may have split due to degradation consistent with some type of chemical or environmental exposure.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

Event Description

The account alleges that during a percutaneous transluminal angioplasty procedure the catheter tip broke into small pieces.No additional procedures/interventions were needed for this patient.No patient injury to report.

• 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: 9176891
• MDR Text Key: 164669229
• Report Number: 3010665433-2019-00067
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00884450038185
• UDI-Public: 00884450038185
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 56535RIM
• Device Lot Number: E1097384
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2017
• 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