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

Model Number 4FC12

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, when the sheath was flushed continuously, an ¿occlusion alarm¿ (alarm from the infusion pump) was triggered.A sheath port check confirmed air ingress.An attempt was made to perform air aspiration but a syringe was unable to be pulled out.The balloon catheter was thus extracted once and air aspiration was performed.Then, the balloon catheter was inserted again and no air was confirmed in the product.Ablation was started but the occlusion alarm was triggered multiple times.The procedure continued and was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files for the date of the event were returned and analyzed.The files show at least ten applications with balloon catheter, 2af284 lot 17118, and eight applications with electrophysiology (ep) catheter, 239f3 lot 15994.No system notices or issues were noted.Further results pending the returned product analysis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Event summary: upon visual inspection of flexcath sheath 4fc12 / 68329-053, results showed the device were intact with no apparent issues.Air aspiration was reproduced when a test arctic front catheter was introduced through the sheath.The unable to aspirate report could not be reproduced.Dissection showed the hemostatic valve was leaking; valve was torn.The sheath failed the test due to leaking homeostatic valve.The sheath 4fc12 is flushed/aspirated upon inserting arctic front advance catheter.The od of the balloon proximal bonding was in specification (less than 0.155 inches).Insertion and retraction tests were performed without friction.In conclusion, the reported issue air ingress during aspiration has been confirmed through testing but not through the data analysis.The reported issue (unable to aspirate) has been not confirmed through the testing and data analysis.The sheath failed the returned product inspection due to a leaking hemostatic valve.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
• 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: 6827622
• MDR Text Key: 83886946
• Report Number: 3002648230-2017-00477
• 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,Followup,Followup
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 68329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2017
• 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: 2AF284 BALLOON CATHETER