MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problem Hypoxia (1918)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

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.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.Referenced article: ¿emergency percutaneous closure of an iatrogenic atrial septal defect causing right-to-left shunt and severe refractory hypoxemia after pulmonary vein isolation.¿ jacc: cardiovascular interventions.2015.Vol.8: no.11., e179-e181.

Event Description

Aznaouridis, konstantinos md, phd; hobson, neil mbchb, md; rigg, christopher bsc, mbchb, da; bragadeesh, thanjavur phd.¿emergency percutaneous closure of an iatrogenic atrial septal defect causing right-to-left shunt and severe refractory hypoxemia after pulmonary vein isolation.¿ jacc: cardiovascular interventions.2015.Vol.8: no.11., e179-e181.The literature publication reports the following patient complications: after the patient underwent a pulmonary vein isolation (pvi) procedure, the patient developed "severe hypoxemia." a trans-esophageal echo-cardiogram showed that the patient had a "continuous right-to-left (r-l) jet through an iatrogenic atrial septal defect (iasd).The patient underwent a emergency trans-catheter closure of the isad.The patient was discharged three days later and "fully functional" eight-weeks post-procedure.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5145101
• MDR Text Key: 28046658
• Report Number: 3002648230-2015-00357
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 09/24/2015

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: Physician
• 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: Not provided
• Initial Date FDA Received: 10/13/2015
• 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; Required Intervention
• Patient Age: 00060 YR