MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the mapping catheter would advance through the balloon catheter.The mapping catheter was removed to be replaced and a kink was noted on the mapping catheter.The mapping catheter and balloon catheter was replaced which resolved the issue.The case was completed with cryo.No patient complications have been reported as a result of this event.

• Brand Name: ACHIEVE MAPPING CATHETER - 20 MM
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11066407
• MDR Text Key: 227361906
• Report Number: 9617601-2020-00042
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2020

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: Health Professional
• Device Expiration Date: 11/08/2021
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Device Lot Number: 218856427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/23/2020
• Date Device Manufactured: 11/08/2019
• 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
• Patient Age: 72 YR