MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP CORONARY SINUS CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number CRYO-UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiomyopathy (1764); Inflammation (1932); Pneumothorax (2012); Tachycardia (2095); Blood Loss (2597); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: competitor laa occlusion device procedure.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 manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/manufacturers.The overall baseline gender characteristics is 50% male and 50% female; the age of the patients was 65 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: ¿left atrial appendage management with the watchman device during hybrid ablation of atrial fibrillation.¿ hindawi journal of interventional cardiology.Volume 2019, article id 4525084, 7 pages.Https://doi.Org/10.1155/2019/4525084.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reported the following patient complications during the use of a coronary sinus catheter.Of note, the complications that occurred were ¿not necessarily related to the device implantation.¿ there was one patient who experienced a pneumothorax, which was drained with a pleural catheter; one patient with transient elevated right hemidiaphragm; one patient with pericarditis; one hospital admission because of tachycardiomyopathy; one patient who needed a blood transfusion two days after the procedure, due to ¿excessive blood¿ loss through the thoracic drain, which occurred on the date of the procedure; for this patient medication given and the bleeding stopped.Of note, multiple patients/manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The status/location of the catheter 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: CORONARY SINUS CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 9856868
• MDR Text Key: 188331930
• Report Number: 3002648230-2020-00164
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: UNKNOWN
• 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: 03/19/2020

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: 03/16/2020
• Initial Date FDA Received: 03/19/2020
• 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: 65 YR