MAUDE Adverse Event Report: MEDTRONIC, INC. FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problem Gas/Air Leak (2946)

Patient Problem Air Embolism (1697)

Event Date 01/01/2020

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.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.Multiple patients were described with the following age/gender: age (b)(6) years (male).Age (b)(6) years (female).A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Clinically manifesting air embolisms in cryoballoon ablation jacc: clinical electrophysiology 2020; 6(9):1067¿72.Https://doi.Org/10.1016/j.Jacep.2020.07.012.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding sheaths during cryoablation procedures.The authors discussed cases of air embolisms and the usefulness of utilizing water buckets to prevent air from being introduced while inserting the catheter into the transseptal sheath.There were nine patients who developed coronary air embolisms and in two patients multiple air bubbles were identified and those patients underwent emergent coronary angiography.All the patients recovered under conservative treatment without any sequela.The disposition of the product is not known.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: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10759838
• MDR Text Key: 213843579
• Report Number: 2182208-2020-02593
• 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
• Report Date: 10/29/2020

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?: 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
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/29/2020
• 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