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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Vascular System (Circulation), Impaired (2572); Pseudoaneurysm (2605)
Event Date 02/24/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that post-operatively to a cryo ablation procedure, a pseudoaneurysm of the left groin was observed through sonography. Also, the patient experienced pain at the puncture site. A thrombin injection was administered. The hospital stay was extended. The case was completed with cryo. It was later that the patient was re-admitted to the hospital for pseudoaneurysm of the left groin again. The issue resolved the next day. This patient was a participant in the cryo af global registry clinical study. No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Event summary: the patient data files showed at least seven applications were performed with catheter 2af284/ 81446 without any issue on the date of the event. It was reported that post-operatively to a cryo ablation procedure, a pseudoaneurysm of the left groin was observed through sonography. The patient was re-admitted to the hospital for pseudoaneurysm of the left groin again. The issue resolved the next day. The patient experienced pain at the puncture site. The sheath was not returned for investigation. There is no indication that the reported adverse event is related to manufacturing. In conclusion, this is a case related to clinical adverse events (left groin pseudoaneurysm, pain). The reported issue was not related to the performance of the cryoablation devices. The sheath was not returned for investigation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
(b)(6) 2018: upon further review, it should have been noted that the patient experienced pain at the puncture site. Additionally, the patient was apart of cryo af global registry clinical study.
 
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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 Key7637668
MDR Text Key112314855
Report Number3002648230-2018-00433
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 08/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/12/2020
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot Number42350
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 Received07/24/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/15/2018
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: 06/26/2018 Patient Sequence Number: 1
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