MAUDE Adverse Event Report: MERIT MERIT; DIAGNOSTIC PERIPHERAL CATHETER: CATHETER

Lot Number 58035MHK1 LOT # E1211948

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 03/01/2018

Event Type  Injury  

Event Description

Tip of mhk1 - 58035mhk1 lot # e1211948 merit diagnostic peripheral catheter detached migrating to unanticipated area.Snare used to retrieve the tip of the catheter.Larger size cath and sheath placement the opposite groin required for retrieval.Additional interventions including conversion is open thrombectomy/protamine needed.Dates of use: (b)(6) 2018.

• Brand Name: MERIT
• Type of Device: DIAGNOSTIC PERIPHERAL CATHETER: CATHETER
• Manufacturer (Section D): MERIT
• MDR Report Key: 7326978
• MDR Text Key: 102113858
• Report Number: MW5075761
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 58035MHK1 LOT # E1211948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2018
• 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
• Treatment: NOT AVAILABLE TO REPORTER.
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR