MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pneumothorax (2012)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant product: 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 device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.The event occurred outside the us.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 device serial numbers.The baseline gender/age characteristic is male/(b)(6) years old 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: ¿prevalence and pre-procedural predictors associated with right phrenic nerve injury in electromyography-guided, second-generation cryoballoon ablation: single large balloon and single 3-minute freeze techniques.¿ jacc clin electrophysiol.2016;2(4):508-514.

Event Description

The literature publication reports the following patient complication while using a mapping catheter: there was one (1) patient with pneumothorax during the puncture of the right subclavian vein.The status/location of the mapping 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: ACHIEVE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6169290
• MDR Text Key: 62220292
• Report Number: 3002648230-2016-00523
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102588
• 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: 11/15/2016

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: 990063-020
• Device Catalogue Number: 990063-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: 11/15/2016
• Supplement Dates FDA Received: 09/28/2017
• 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
• Treatment: FLEXCATH ADVANCE STEERABLE SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR