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U.S. Department of Health and Human Services

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

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MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE Back to Search Results
Model Number 4FC12
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)
Patient Problems Death (1802); Endocarditis (1834); Fistula (1862); Laceration(s) of Esophagus (2398)
Event Date 11/08/2018
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: arctic front advance cardiac cryoablation catheter. Medtronic 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. The baseline gender/age of the patients represented in the article is male/54 years old. Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers. The model listed in the report is a representative of the model family, as there is no specific model listed. 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. The date of death is not available at the time of this report, as there is no indication of specific lot number/patient information. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: ¿double factor single shot to diminish complications in cryoballoon ablation procedures for atrial fibrillation. ¿ journal of interventional cardiac electrophysiology. Https://doi. Org/ 10. 1007/s10840-018-0483-3. Published online 2018-11-08. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The literature publication reports the following patient complications while using a cryoablation balloon/sheath catheter/mapping catheter: there was one patient who, two-weeks post ablation procedure, presented with an atrial-esophageal fistula ¿related to the low temperature reached¿ in the left inferior pulmonary vein, endocarditis, and ¿disseminated embolism. ¿ the patient died prior to surgery. The cause of death has been requested, but not yet received. There was also one (1) patient who experienced cardiac tamponade during balloon manipulation, which required ¿urgent surgery. ¿ there were also six (6) patients with transient phrenic nerve palsy (pnp), all of which resolved. There were three (3) patients with a groin hematoma, all of which did not require any intervention. There were also two (2) patients who experienced pericardial effusion, with no intervention taken. There was one (1) patient who had phrenic nerve palsy (pnp), transient ischemic attack (tia), and air embolism, with no mention of intervention/resolution. There was another patient who and a stroke and pnp, again with no mention of intervention/resolution. One (1) patient had 50% pulmonary vein stenosis. Further follow up did no yet yield any additional information. The status/location of the cryoballoon catheter/sheath catheter/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.
 
Event Description
Additional information was obtained through follow up with the author who indicated that there were no specific allegations or complications against the products. There was no other medical/surgical intervention taken. The author also stated that "all patients are alive and doing well except for the one with the fistula. " no further information was provided.
 
Manufacturer Narrative
Further review prompted a change in the device analysis results. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameFLEXCATH ADVANCE STEERABLE SHEATH
Type of DeviceCATHETER, STEERABLE
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
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key8135135
MDR Text Key129392034
Report Number3002648230-2018-00916
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/05/2018 Patient Sequence Number: 1
Treatment
ACHIEVE MAPPING CATHETER
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