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

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.

• Brand Name: EMPIRA RX PTCA 12 X 2.50
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): CREGANNA; 1353 dell avenue; campbell CA 95008
• MDR Report Key: 10782072
• MDR Text Key: 214506408
• Report Number: 1016427-2020-04504
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00812917020237
• UDI-Public: 00812917020237
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• 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 Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 85R12250S
• Device Catalogue Number: 85R12250S
• Device Lot Number: CE1024421
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2020
• Date Manufacturer Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death