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

Model Number 4FC12

Device Problems Kinked (1339); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoxia (1918); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/25/2017

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, systolic and diastolic pressures were out of the expected range, and oxygen through the pulsiometer were low.A transthoracic echography was performed and a tamponade was observed.Pericardiocentesis was performed.Medication was administered which controlled the blood effusion.Blood was transfused.The patient stabilized.It was noted that the tamponade occurred when the sheath was moved from the right side to the left side.The case was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: the patient data files showed at least fourteen applications were performed with catheter 2af283/89218-37 on the date of the event and did not show any issues however, some injections were non-sustained.Clinical issues (cardiac tamponade) encountered during the procedure.In conclusion, this is a clinical issue (cardiac tamponade) encountered during the case.The reported issue (cardiac tamponade) cannot confirm through data analysis.Pending results of the analysis on returned product.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: not able to disassociate or associate the malfunction from the adverse event.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the data files and sheath 4fc12, with lot number 53075 were returned and analyzed.The data files showed at least 14 applications were performed with the balloon catheter on the date of the event and did not show any issues.Visual inspection of the sheath showed the shaft was kinked and twisted twice at 1.6 and 2.6 inches from the tip.The sheath¿s distal tip was intact; no fractures or breaks were noticed.There was no teflon delamination noticed at the tip of the sheath¿s shaft.Functional testing showed the deflection worked as per specification.Several clinical issues (cardiac tamponade, pericardial effusion, hypoxia and hypotension) were encountered during the procedure.There is insufficient evidence to conclude that the malfunctions are related to the clinical issues.If information is provided in the future, a supplemental report will be issued.

Event Description

The sheath subsequently tested out of specification per the manufacturer's investigation.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6998829
• MDR Text Key: 90947062
• Report Number: 3002648230-2017-00592
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup,Followup,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2018
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 53075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 11/03/2017
• Supplement Dates Manufacturer Received: 11/27/2017; 12/19/2017; 12/19/2017
• Supplement Dates FDA Received: 12/19/2017; 01/17/2018; 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2016
• 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
• Treatment: 990063-020 MAPPING CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention