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); Cardiac Tamponade (2226); Loss of consciousness (2418)

Event Date 03/30/2020

Event Type  Injury  

Manufacturer Narrative

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 patient's blood pressure dropped and the patient lost consciousness.Cardiac tamponade was observed.The case was aborted.The patient's hospitalization was extended.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: b2.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: b2 product event summary: the data files were returned and analyzed.The data files showed at least eight applications were performed with 2af283 balloon catheter with lot 72695 without any issue on the date of the event.The clinical issue (cardiac tamponade) occurred during procedure.There is no indication of relation of the adverse event to the performance and malfunction of the product.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
• MDR Report Key: 9934163
• MDR Text Key: 188335516
• Report Number: 3002648230-2020-00214
• 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,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0009945136
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 990063-020 MAPPING CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 67 YR
• Patient Weight: 100