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 Nausea (1970); Paresis (1998); Tissue Damage (2104)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: arctic front advance cardiac cryoablation 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. Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/methods/manufacturers. The overall baseline gender characteristics is male; the age of the patients was 63 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: ¿clinical impact of rapid ventricular pacing on the left atrial posterior wall isolation by a cryoballoon application: a randomized controlled trial. ¿ j interv card electrophysiol. 2020 jan 2. Pii: 10. 1007/s10840-019-00641-9. Doi: 10. 1007/s10840-019-00641-9. If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reported the following patient complications during a procedure using a cryoballoon ablation catheter system. There were seventeen (17) patients who experienced esophageal injury or ¿mild¿ erosion; with no indication of treatment/resolution indicated. There were seven (7) patients who showed ¿mucosal redness;¿ with no indication of treatment/resolution. Fourteen of the patients experienced ¿gastric hypomotility;¿ even though the patients had been in a fasting state. One of these 14 patients had nausea, which disappeared in two days. There were three (3) patients who experienced transient phrenic nerve palsy (pnp); all of which resolved by the end of the ablation procedure. The patient recovered after medical therapy was administered. Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/methods/manufacturers. The status/location of the cryoballoon catheter 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.

• 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: 10111698
• MDR Text Key: 194618169
• Report Number: 3002648230-2020-00301
• 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

• Type of Report: Initial,Followup
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• 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: 06/11/2020
• 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: 06/02/2020 Patient Sequence Number: 1