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

Model Number 4FC12

Device Problems Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed. The data files showed at least seven applications were performed with balloon catheter 2af284 with lot number 21662 without any issues present. In conclusion, the reported pulmonary vein damage could not be confirmed through analysis of data files. There is no indication of relation of adverse event to the performance of the cryo device. The sheath has been returned and physical analysis is pending. If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, a coronary angiography was attempted; however, the contrast agent did not flow, and concentrated in one area. The physician determined the pulmonary vein was damaged. An intracardiac echocardiogram was performed, confirming there was no pericardial effusion. The case was completed with radiofrequency. The patient recovered at a later date. No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the sheath 4fc12 with lot number 85382 was returned and analyzed. Visual inspection of the sheath showed that the shaft, was kinked at 7. 2 inches. The sheath tip was with no sharp edges. In conclusion, the reported clinical issue (pulmonary vein damage) occurred during cryo ablation procedure and cannot be confirmed through testing. The sheath failed the returned product inspection due to shaft kink. There is no indication of relation of the adverse event to the finding of the mapping catheter. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the sheath 4fc12 with lot number 85382 was returned and analyzed. Visual inspection of the sheath showed that the shaft, was kinked at 7. 2 inches. The sheath tip was with no sharp edges. In conclusion, the reported clinical issue (pulmonary vein damage) occurred during cryo ablation procedure and cannot be confirmed through testing. The sheath failed the returned product inspection due to shaft kink. There is no indication of relation of the adverse event to the finding of the sheath. If information is provided in the future, a supplemental report will be issued.

• 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
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8820029
• MDR Text Key: 152010866
• Report Number: 3002648230-2019-00525
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 04/15/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 85382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/23/2019 Patient Sequence Number: 1

Treatment

2AF284 BALLOON CATHETER, 2ACH20 MAPPING CATHETER