MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP PV-TRACKER GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number 990045

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

Patient Problems Hematoma (1884); Cardiac Tamponade (2226)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

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 baseline gender/age characteristic is male/58 years old.Of note, multiple patients, were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.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: ¿atrial fibrillation ablation with multipolar phased-radiofrequency catheter: ¿the learning curve effect for procedural parameters, but not for the long-term outcome.¿ journal of clinical medicine.2019; 8(10).Doi://10.3390/jcm8101589.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reported the following patient complications while using a phased radio frequency ablation catheter: there was one (1) patient who had cardiac tamponade which was managed with pericardiocentesis.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers.The status/disposition of the guidewire 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: PV-TRACKER GUIDE WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• 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: 9323383
• MDR Text Key: 166900368
• Report Number: 3002648230-2019-00777
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K935170
• 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: 11/14/2019

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: 990045
• Device Catalogue Number: 990045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2019
• Initial Date FDA Received: 11/14/2019
• 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: 58 YR