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 Fistula (1862); Pseudoaneurysm (2605); Pericardial Effusion (3271)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. This event occurred outside the us. Patient information is limited due to confidentiality concerns. Of note, multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers. The baseline gender/age characteristics is male/(b)(6) years old. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: efficacy of cryoablation in idiopathic and non-idiopathic atrial fibrillation patients. 2021. 122 (2). 89¿94. Doi: 10. 4149/bll_2021_013. If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding cryoablation in idiopathic and non-idiopathic atrial fibrillation (af) patients. The article reports patients that had pericardial effusion which required pericardiocentesis, groin complications, such as arteriovenous fistulas and pseudoaneurysms, which were treated surgically. The status/disposition of the catheters and sheaths is unknown. No further patient complications have been reported as a result of this event. Further follow up did not yet yield any additional information.

• 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: 11636098
• MDR Text Key: 245099965
• Report Number: 3002648230-2021-00166
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/08/2021 Patient Sequence Number: 1