MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FREEZOR XTRA CARDIAC CRYOABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 217F3

Device Problem Break (1069)

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

Event Date 01/18/2022

Event Type  malfunction  

Event Description

After a completed case, the electrophysiology (ep) catheter subsequently tested out of specification per the manufacturer's investigation.

Manufacturer Narrative

Product event summary: the 217f3 electrophysiology (ep) catheter with lot number 13189 was returned and analyzed.During external visual inspection of the shaft segment, a kink was observed on the shaft at attachment to the handle (strain relief) and a snapped shaft was observed seven inches from the catheter strain relief.The pull wire, injection tube and temperature/signal wires were not cut.The ep catheter smart chip data was reviewed.Data indicated that the catheter was used for 19 applications on the reported event date.During system performance testing with the console, the console initiated a "coaxial connector" animation warning (high baseline flow due to a cut shaft).The steering mechanism worked despite the shaft damages but not as initially intended.In conclusion, the ep catheter failed the returned product inspection due to a shaft kink and a snapped shaft.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREEZOR XTRA CARDIAC CRYOABLATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13930752
• MDR Text Key: 288697125
• Report Number: 3002648230-2022-00118
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2022
• Device Model Number: 217F3
• Device Catalogue Number: 217F3
• Device Lot Number: 13189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2022
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2020
• 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 Sex: Male