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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREGANNA EMPIRA NC RX PTCA 10 X 3.50; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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CREGANNA EMPIRA NC RX PTCA 10 X 3.50; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 75R10350N
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/19/2020
Event Type  Injury  
Event Description
During a distal end of the right coronary procedure, the balloon of a 10mm x 3.5mm empira non-complaint (nc) rapid exchange (rx) percutaneous transluminal coronary angioplasty (ptca) balloon catheter burst when it hits 16 atmospheres and it was completely separated from the delivery shaft.The balloon¿s body was removed from the patient by surgery.At the time of the procedure, the target lesion is calcified with eighty percent stenosis.The device was stored, handled, and prepped per the instruction for use (ifu).There were no damages noted to the product packaging upon inspection prior to use.There were no difficulties removing the product from the package, the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.The shipping stylet and balloon cover were removed after submerging in heparinized saline solution.A competitor's contrast media and inflation device was used.The inflation device was successfully used with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve, the guide catheter, or through the vessel.There was no difficulty crossing the lesion.The catheter has never been in an acute bend.There was no difficulty tracking towards the lesion.Images are available for review.The device is expected to be returned for evaluation.No other information was provided.
 
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Brand Name
EMPIRA NC RX PTCA 10 X 3.50
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
CREGANNA
1353 dell avenue
campbell CA 95008
MDR Report Key10179737
MDR Text Key196002723
Report Number1016427-2020-04054
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/22/2020
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 Health Professional
Device Expiration Date06/30/2021
Device Model Number75R10350N
Device Catalogue Number75R10350N
Device Lot NumberCE1021717
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/22/2020
Distributor Facility Aware Date05/19/2020
Device Age11 MO
Event Location Hospital
Date Report to Manufacturer06/22/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
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