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

Model Number CRYO-UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

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 were noted in the article; however, a one to one correlation could not be made with unique 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: ¿second-generation cryoballoon ablation as a first-line treatment of symptomatic atrial fibrillation: two-year outcome and predictors of recurrence after a single procedure.¿ international journal of cardiology 259 (2018) 76¿81.Https://doi.Org/10.1016/j.Ijcard.2017.11.011.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 cryoablation balloon system: there were 16 patients who experienced phrenic nerve palsy (pnp); all of which recovered during the six-month follow up period.There were seven (7) patients who experienced groin hematomas which were treated ¿conservatively.¿ one (1) patient had pericardial effusion, but it did not require any treatment.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique device lot numbers.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.

• Brand Name: UNKNOWN
• 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: 7434761
• MDR Text Key: 105629861
• Report Number: 3002648230-2018-00229
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/16/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR