MAUDE Adverse Event Report: MERIT MEDICAL, INC. 4F PEDIATRIC PIGTAIL CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number PED-PIG-VSC-2B

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Information (3190)

Event Date 03/27/2014

Event Type  malfunction  

Event Description

Catheter would not accept a 0.035 guidewire during a cardiac cath procedure.Another catheter was opened and worked fine.

• Brand Name: 4F PEDIATRIC PIGTAIL CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MERIT MEDICAL, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 3850486
• MDR Text Key: 4407214
• Report Number: 3850486
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/29/2014

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?: Yes
• Device Operator: Physician
• Device Model Number: PED-PIG-VSC-2B
• Device Catalogue Number: 4408-2M65
• Device Lot Number: E551382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Weight: 10