MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. IMPRESS 4F X 65 CM BERN CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 46538BER

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/27/2021

Event Type  Injury  

Event Description

Distal portion of catheter broke off and was left in patient during sheath exchange.Physician was successful in retrieving broken portion of catheter with snare kit.Fda safety report id# (b)(4).

• Brand Name: IMPRESS 4F X 65 CM BERN CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; south jordan UT
• MDR Report Key: 12737916
• MDR Text Key: 279823699
• Report Number: MW5105064
• Device Sequence Number: 1
• Product Code: DQO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 46538BER
• Device Lot Number: E2092103
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Weight: 48