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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE

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MEDTRONIC MEXICO S. DE R.L. DE CV 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 Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Event Date 10/27/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical product: 990063-020 mapping catheter. Product event summary: the data files were returned and analyzed. The data files showed that system notice 50028 (indicating that there was a problem with the injection process) was received on the date of the event. In conclusion, the clinical issue (pericardial effusion and hypotension) occurred during the procedure. There is no indication of a relation of the adverse events to the performance and malfunction of the product. In conclusion the physical product was not returned for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that during a cryo ablation procedure when the left superior pulmonary vein (lspv) and the left common pulmonary vein (lcpv) were ablated, the esophageal temperature dropped rapidly. The physician attempted to cannulate the right sided veins. The physician returned to the left sided veins and attempted two more ablations where the balloon was inflated and deflated. An effusion was noted. The patient's blood pressure started to decline. Pericardiocentesis was performed and the patient stabilized. The case was aborted and the patient was under general anesthesia. It was reported that the patient was small and had a difficult anatomy. Per the physician, the effusion likely occurred during the cannulation attempts of the right sided veins. It was visualized on fluoroscopy and on a non-medtronic mapping system, that the physician led with the mapping catheter the entire procedure. It was also reported a failure to deliver refrigerant occurred sometime during the procedure. No further patient complications have been reported as a result of this event.
 
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Brand NameFLEXCATH ADVANCE STEERABLE SHEATH
Type of DeviceCATHETER, STEERABLE
Manufacturer (Section D)
MEDTRONIC MEXICO S. DE R.L. DE CV
av. paseo del cucapah #10510
tijuana,bc 22210
MX 22210
Manufacturer (Section G)
MEDTRONIC MEXICO S. DE R.L. DE CV
av. paseo del cucapah #10510
tijuana,bc 22210
MX 22210
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key13026446
MDR Text Key287613299
Report Number3002648230-2021-00577
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4FC12
Device Catalogue Number4FC12
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
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: 12/17/2021 Patient Sequence Number: 1
Treatment
AFAPRO28 BALLOON CATHETER
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