MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problems Compatibility Problem (2960); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files found system notice# 50012 ¿the refrigerant delivery path is obstructed¿ in first and second application and also system notice #50032 ¿the safety system has detected a compromised outer vacuum¿ in the third application with a non-returned balloon catheter 2af283 with lot number 68459.The files showed at least four applications were performed with this catheter on the date of the event.Additional data files showed system notice #50012 in the beginning of the ablation phase of first application and system notice #50032 in the applications six through thirteen with a non-returned balloon catheter 2af284 with lot number 52648-32.The files showed at least 13 applications were performed with this catheter on the date of the event.In conclusion, the sheath was not returned for investigation.The product issue reported is not likely to cause or contribute to a death or serious injury; however, the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.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 balloon was unable to be retracted back into the sheath.The manual retraction technique was performed without success.The case was aborted and the patient was under general anesthesia.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the sheath 4fc12 with lot number 54624 was returned and analyzed.Visual inspection of the sheath showed the shaft was ribbed close to the tip, which most likely occurred during an attempt to retract the balloon into the sheath.In conclusion, the sheath failed the returned product inspection due to kink as a result of the retraction of the balloon catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

The sheath subsequently tested out of specification per the manufacturer's investigation.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 9430576
• MDR Text Key: 170472137
• Report Number: 3002648230-2019-00824
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 54624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR