MAUDE Adverse Event Report: CREGANNA EMPIRA NC RX PTCA 10 X 3.00; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 75R10300N

Device Problems Break (1069); Deflation Problem (1149)

Patient Problems Cardiac Arrest (1762); Brain Injury (2219)

Event Date 06/21/2017

Event Type  Injury  

Event Description

As reported, the physician used an empira nc 3mmx10mm to post-dilate an implanted non-cordis stent in the lesion.The physician inflated the balloon at multiple atmospheres (atm) for different lengths of time; however, the balloon completely shattered on the shaft, proximal to the balloon.The proximal end of the balloon catheter was easily pulled out of the patient; however, the distal end of the balloon remained inside the patient.The balloon would not deflate.The physician then used a guideliner and a snare device to retract the balloon.While retracting the balloon, the stent that was deployed in the left main (lm) coronary artery was removed.The physician then post-dilated the lesion with an nc emerge.The physician used a non-cordis product to stent the lm again.The procedure was successfully completed.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted when the device was removed from the packaging.There was no difficulty in removing the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover.The device was prepped per the ifu.There were no kinks nor other damages noted prior to inserting the product the product into the patient.Omnipaque contrast media was used.The contrast to saline ratio was 50/50.Indeflator abbott inflation device was used.Initially, the physician had pre-dilated the lesion in the lm a few times with different sized balloons and a cutting balloon.There was difficulty crossing the lesion with a pre-dilatation balloon and the stent.There was no difficulty crossing the lesion with the post-dilatation balloon.The balloon inflated normally.The balloon was inflated multiple times prior to the burst.The balloon was not caught in the lesion.The balloon stayed inflated after rupture and had to be retracted with a snare device.The balloon was caught in the deployed stent, and the stent came out with the balloon.The patient is stable but still hospitalized because of neuro injury unrelated to the procedure but related to cardiac arrest.The brain suffered injury from the cardiac arrest.The cath lab log and cds of both procedures are available for return and review.However, the product is not available for analysis.The target lesion was the left main coronary artery.The lesion was heavily calcified with critical stenosis.

• Brand Name: EMPIRA NC RX PTCA 10 X 3.00
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): CREGANNA; 1353 dell avenue; campbell CA 95008
• MDR Report Key: 6873870
• MDR Text Key: 86561517
• Report Number: 1016427-2017-00590
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75R10300N
• Device Catalogue Number: 75R10300N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/23/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2017
• 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): Required Intervention