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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CREGANNA EMPIRA RX PTCA 12 X 2.50 CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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CREGANNA EMPIRA RX PTCA 12 X 2.50 CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 85R12250S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Thrombosis (2100)
Event Date 10/08/2020
Event Type  Death  
Event Description
As reported, the patient was first admitted and implanted with 3. 5 x 24 unknown stent from left marginal (lm) to left anterior descending (lad) and the opening of the left circumflex (lcx) was 50-60% stenosis. The operation used a restrained balloon and kiss technique. Post-operative angiography showed 80% lad stenosis was resolved. Four months thirteen days post unknown stent implantation; the patient had recurrent chest pain. An angiography showed, lm artery was unobstructed, the middle lad artery had 90% stenosis and the lcx artery had 80% stenosis. Initially, the doctor¿s strategy was to use a conventional balloon dilatation. Before the operation, he recommended that the patient be treated with a medicine balloon at the opening of lcx, but the family considers economic factors, it was not used. Later, the doctor planned to use balloon dilatation in the lad to see the situation. During the operation, a 2. 50 x 12 empira rapid exchange (rx) percutaneous transluminal coronary angioplasty (ptca) balloon catheter expands the lad stent at 10 atmospheres (atm) and 14 atm. The stenosis was resolved, thrombolysis in myocardial infarction (timi) blood flow was level 3 and then the empira balloon was exchanged to lcx artery opening for 12 atm expansion. Another 3. 5 x 12 non-cordis balloon catheter was used to expand the lad stent; at this time, the patient feels chest tightness. The blood in the lcx was whitish on the angiogram. The user continues to expand the lcx artery with the 2. 5 x 12 empira balloon. The assistant continues to pressurize the balloon several times. A thrombus was noted. At this time, the expert is going to take a new 2. 5 x 12 empira balloon to continue the expansion but it was not used; they begin to rescue the patient. Rescue measures included femoral artery puncture, ¿rise¿ and ventilator. The patient died during the procedure. The doctor described that across the lm, lcx opening there was an air embolism at the distal end of the lad and the blood flow was not good. The device will be returned for evaluation.
 
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Brand NameEMPIRA RX PTCA 12 X 2.50
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
CREGANNA
1353 dell avenue
campbell CA 95008
MDR Report Key10782072
MDR Text Key214506408
Report Number1016427-2020-04504
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
Type of Report Initial
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number85R12250S
Device Catalogue Number85R12250S
Device Lot NumberCE1024421
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/09/2020
Event Location Hospital
Date Report to Manufacturer11/03/2020
Date Manufacturer Received10/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/03/2020 Patient Sequence Number: 1
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