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

Catalog Number 56535RIM

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/26/2016

Event Type  Injury  

Manufacturer Narrative

One unit was returned for evaluation.The device was examined visually and microscopically.The complaint is confirmed.The root cause is attributed to significant force applied to the fusezone.The device history record was reviewed and no exception documents were found.The complaint database was reviewed and no similar complaints were found for this lot number.

Event Description

The customer reported that when they were advancing the catheter over the terumo glide advantage wire and pulling back over the bifurcation the tip of the catheter broke off.The physician went over the wire and retrieved the tip of the catheter with a snare.The physician believes the tip of the catheter got hung up on the terumo glidewire while going over a tortuous bifurcation causing extra pressure on the end of the catheter.No injuries to the patient were reported.

• Brand Name: IMPRESS ANGIOGRAPHIC CATHETER
• Type of Device: ANGIOGRAPHIC 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: casey hughes, ms, cqe ; 1600 west merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6111641
• MDR Text Key: 60281058
• Report Number: 3010665433-2016-00066
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 56535RIM
• Device Lot Number: E1014968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• 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: TERUMO GLIDE ADVANTAGE WIRE
• Patient Outcome(s): Required Intervention