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 Problem Pericardial Effusion (3271)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Arctic front advance cardiac cryoablation catheter.Medtronic cryocath was made aware of this event through a search of literature publications.It was not possible to ascertain specific patient or 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.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The baseline gender/age characteristic is male/(b)(6) for the patients referenced in the article.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: ¿comparison of the incidences of complications after second-generation cryoballoon ablation of atrial fibrillation using vitamin k antagonists versus novel oral anticoagulants.¿ the american journal of cardiology (www.Ajconline.Org).Http://dx.Doi.Org/10.1016/j.Amjcard.2017.04.012.

Event Description

The literature publication reports the following patient complication while using a sheath catheter: multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.There were also six (6) patients with ¿mild pericardial effusion without hemodynamical impact that required pericardiocentesis or intervention.¿ the status/location of the sheath catheter is unknown.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: 6645576
• MDR Text Key: 77701332
• Report Number: 3002648230-2017-00279
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2017
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR