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

Model Number 4FC12

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem ST Segment Elevation (2059)

Event Date 01/18/2019

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed four applications were performed with balloon catheter 2af284 lot number 39238 on the date of the event without any issues.A clinical issue (st elevation) occurred during the case.In conclusion, there is no indication of the performance of the sheath in relation to the clinical issue.The reported air ingress issue could not be confirmed through data analysis.The reported sheath 4fc12 lot number 45091 was not returned for investigation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, st elevation was observed.Nitroglycerin was administered with resolve.Additionally, a bubble was observed in the patient's angiogram, which was reported to indicate air ingress via an unknown route.The case was completed with cryo.No further patient complications have been reported as a result of this event.

• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8337392
• MDR Text Key: 136106995
• Report Number: 3002648230-2019-00085
• 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: Physician
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 45091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2018
• 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 Outcome(s): Required Intervention