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 Problem Hemorrhage/Bleeding (1888)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that following a cryo ablation procedure that was completed with cryo, the patient had bleeding at the access site.A hemostatic agent was administered and the patient was placed under monitoring.The patient's hospital stay was extended.A computerized tomography (ct) scan showed no problem was observed.The patient was discharged and no recurrence was noted.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed at least six applications were performed with an afapro28 balloon catheter with lot 56673 on the date of the event.It was observed there was a pressure and flow overshoot in the beginning of the ablation #4, #5 and #6.The balloon was thawed on 5th application during transition phase due to temperature raised to 20 °c.In conclusion, a clinical issues (access site complications and bleeding) occurred following the procedure.There is no indication of a relation of the adverse event to the performance and malfunction of the product.The physical product is not available for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

Further incoming information indicated the patient's hospital was not extended.

• 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: 10951128
• MDR Text Key: 219882034
• Report Number: 3002648230-2020-00632
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2022
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010342343
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFAPRO28 BALLOON CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention