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

Model Number 4FC12

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Vascular System (Circulation), Impaired (2572); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant products: achieve mapping catheter. Medtronic was made aware of this event through a search of literature publications. It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events. This information is based entirely on journal literature. This event occurred outside the us. All information provided is included in this report. Patient information is limited due to confidentiality concerns. Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique lot numbers. The model listed in the report is a representative of the model family, as there is no specific model listed. The baseline gender/age of the patients represented in the article is male/57 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: ¿single 3-min freeze per vein ablation strategy with the second-generation cryoballoon for atrial fibrillation in a large cohort of patients: long term outcome after a single procedure. ¿ journal of interventional cardiac electrophysiology. Published online 13june2018. Https://doi. Org/10. 1007/s10840-018-0393-4. If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reports the following patient complications while using a cryoablation balloon ablation system: there were eight (8) patients who experienced phrenic nerve palsy (pnp); all, but one, cases had resolved by hospital discharge. The one (1) patient had persistent pnp at the final follow up. There were ten (10) patients who experienced vascular access complications; some of which resulted in a longer hospitalization, along with one surgical intervention. The status/location of the cryoballoon system is unknown. Further follow up did not yet yield any additional information. No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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: 7735814
• MDR Text Key: 115589405
• Report Number: 3002648230-2018-00515
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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

• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• 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: 08/08/2018
• 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: 07/31/2018 Patient Sequence Number: 1

Treatment

ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER