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

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.

• 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 Key: 10179737
• MDR Text Key: 196002723
• Report Number: 1016427-2020-04054
• Device Sequence Number: 1
• Product Code: LOX
• 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 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 Date: 06/30/2021
• Device Model Number: 75R10350N
• Device Catalogue Number: 75R10350N
• Device Lot Number: CE1021717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2020
• Distributor Facility Aware Date: 05/19/2020
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1