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

Model Number CRYO-UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Blood Loss (2597)

Event Date 02/01/2017

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.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline gender/age of the patients represented in the article is male/61 years old.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with unique manufacturer/methods/product lot numbers.The model listed in the report is a representative of the model family, as there is no specific model listed.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.Referenced article: ¿reconnection rate and long-term outcome with adenosine provocation during cryoballoon ablation for pulmonary vein isolation.¿ journal of atrial fibrillation.Feb-march 2017.Volume 9: issue 5.Www.Jafib.Com.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reports the following patient complication while using a cryoablation balloon/sheath catheter/mapping catheter: there were three (3) patients who experienced ¿transient¿ phrenic nerve palsy (pnp); with unknown treatment/resolution.There were two (2) patients with procedural bleeding complications; four (4) patients with ¿other¿ procedural complications.There was one (1) patient with a reported perforation during the procedure; with unknown treatment/resolution.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The status/location of the cryoballoon catheter/sheath catheter/mapping catheter is unknown.No further patient complications have been reported as a result of this event.

• Brand Name: SHEATH CATHETER
• 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: 7210479
• MDR Text Key: 97919636
• Report Number: 3002648230-2018-00045
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CRYO-UNKNOWN
• Device Catalogue Number: CRYO-UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ACHIEVE MAPPING CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR