MAUDE Adverse Event Report: MEDTRONIC ACHIEVE MAPPING CATHETER

Model Number ACHIEVE

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Information (3190)

Event Date 03/11/2016

Event Type  Injury  

Event Description

Catheter was placed in pulmonary vein during cryo-ablation pulmonary vein isolation for atrial fibrillation.Unable to get clean electrical signal from tip of catheter for atrial fibrillation.Unable to get clean electrical signal from lip of catheter for monitoring of intracardiac egms.Connecting cable changed.Tried different connection pins to monitor system.Catheter was changed out for new one with resolution of issue.

• Brand Name: ACHIEVE MAPPING CATHETER
• Type of Device: ACHIEVE MAPPING CATHETER
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 5532304
• MDR Text Key: 41472065
• Report Number: MW5061299
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Public: (01)0064E169467385(17)171231(10)
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2017
• Device Model Number: ACHIEVE
• Device Catalogue Number: 990063-020
• Device Lot Number: 210596418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• 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: 77 YR
• Patient Weight: 71