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

Model Number 4FC12

Device Problems Gas/Air Leak (2946); Appropriate Term/Code Not Available (3191)

Patient Problem Air Embolism (1697)

Event Date 06/01/2018

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 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.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The model listed in the report is a representative of the model family, as there is no specific model listed.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 of the patients represented in the article is male/62 years old.Without a lot number or device serial number, the manufacturing date cannot be determined.Referenced article: ¿silent cerebral events/lesions after second-generation cryoballoon ablation ~ how can we reduce the risk of silent strokes?¿ heart rhythm (2018), doi:10.1016/j.Hrthm.2018.07.011.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 cryoballoon ablation catheter system: there were patients who had asymptomatic silent cerebral lesions/silent cerebral embolic events detected during the ablation procedure.There were also patients with ¿transient¿ st elevations.There was also a mention of a ¿product misuse¿ massaging balloon technique that may have been used; however, there was no indication of patient injury.The article reports that there were no complications.The status/location of the system is unknown.Additional information was obtained from follow up with the physician/author who indicated that the issues were related to the products, and that the products were discarded; therefore, no lot numbers are available.Also, the physician reported that there were no injuries due to the ¿balloon massage.¿ no further information was provided.

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: 7806662
• MDR Text Key: 117914960
• Report Number: 3002648230-2018-00564
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 07/23/2018
• 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
• Treatment: ACHIEVE MAPPING CATHETER
• Patient Outcome(s): Other
• Patient Age: 62 YR