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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problem Pseudoaneurysm (2605)

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.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline characteristics of the patients referenced in the article is gender/age is male/64 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.Referenced article: "procedural and biophysical indicators of durable pulmonary vein isolation during cryoballoon ablation of atrial fibrillation." http://dx.Doi.Org/10.1016/j.Hrthm.2015.10.033.Heart rhythm.2015.S1547-5271(15)01363-6.(b)(4).

Event Description

"procedural and biophysical indicators of durable pulmonary vein isolation during cryoballoon ablation of atrial fibrillation." htt p://dx.Doi.Org/10.1016/j.Hrthm.2015.10.033.Heart rhythm.2015.S1547-5271(15)01363-6.Arash aryana ms, md, giacomo mugnai md, sheldon m.Singh md, deep k.Pujara mbbs, carlo de asmundis md, phd, steve k.Singh msc, md, mark r.Bowers ms, md, pedro brugada md, phd, andrɠdila md, phd, padraig gearoid oill md, gian-battista chierchia md, phd, procedural and biophysical indicators of durable pulmonary vein isolation during cryoballoon ablation of atrial fibrillation, heart rhythm, http://dx.Doi.Org/1 0.1016/j.Hrthm.2015.10.033.The literature publication reports the following patient complication: femoral pseudo-aneurysm.

Event Description

"procedural and biophysical indicators of durable pulmonary vein isolation during cryoballoon ablation of atrial fibrillation." htt p://dx.Doi.Org/10.1016/j.Hrthm.2015.10.033.Heart rhythm.2015.S1547-5271(15)01363-6.Arash aryana ms, md, giacomo mugnai md, sheldon m.Singh md, deep k.Pujara mbbs, carlo de asmundis md, phd, steve k.Singh msc, md, mark r.Bowers ms, md, pedro brugada md, phd, andre d'avila md, phd, padraig gearoid o'neill md, gian-battista chierchia md, phd, procedural and biophysical indicators of durable pulmonary vein isolation during cryoballoon ablation of atrial fibrillation, heart rhythm, http://dx.Doi.Org/1 0.1016/j.Hrthm.2015.10.033.The literature publication reports the following patient complications: transient and persistent phrenic nerve palsy (pnp), femoral pseudo-aneurysm, and gastroparesis.

• Brand Name: FLEXCATH 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: 5255766
• MDR Text Key: 32393669
• Report Number: 3002648230-2015-00427
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• 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
• Patient Age: 00064 YR