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

Model Number 4FC12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

Product event summary: data files were returned and analyzed.The patient files showed at least five applications were performed with balloon catheter afapro28 with lot 38676.The clinical issue (cardiac tamponade and perforation) occurred during the procedure.There is no indication of relation of adverse event to the performance and malfunction of the product.In conclusion, the physical product was not returned for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, cardiac tamponade and perforation of the right inferior pulmonary vein (ripv) were suspected by the sheath.The patient developed slight hypotension, and their oxygen saturation decreased slightly.The contrast agent leaked from the damaged pulmonary vein (pv) towards the bronchial tubes.Aspiration of the leaked contrast agent was performed and as a result, the blood pressure became normal.The case was aborted.The patient was later discharged without issue or extension of hospitalization.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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9828915
• MDR Text Key: 183278621
• Report Number: 3002648230-2020-00154
• 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: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0009925302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2019
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 77 YR