MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	7213
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed target lesion was located in the averagely tortuous and severely calcified mid right coronary artery.After a staged rotablator, the lesion was dilated with an emerge balloon catheter without issues, but upon removal from the patient's body the shaft then snapped 1/3 from the hub inside the 8fr guide catheter.The wire was pulled back into the guide catheter and snared the broken shaft without removing the guide catheter.The lesion then dilated with a different balloon catheter.A 2.50 x 32 synergy drug-eluting stent was advanced but failed to cross and so another balloon was used to pre-dilate the lesion.The 2.50 x 32 stent was advanced for the second time but the shaft broke at the mid portion of the catheter while advancing into the guide.The stent was pulled out from the guide catheter without removing the device from it.The procedure was completed with a different device.No patient complications were reported and the patient remained stable all throughout the procedure.
Event or Problem Description
It was reported that shaft break occurred.The 85% stenosed target lesion was located in the averagely tortuous and severely calcified mid right coronary artery.After a staged rotablator, the lesion was dilated with an emerge balloon catheter without issues, but upon removal from the patient's body the shaft then snapped 1/3 from the hub inside the 8fr guide catheter.The wire was pulled back into the guide catheter and snared the broken shaft without removing the guide catheter.The lesion then dilated with a different balloon catheter.A 2.50 x 32 synergy drug-eluting stent was advanced but failed to cross and so another balloon was used to pre-dilate the lesion.The 2.50 x 32 stent was advanced for the second time but the shaft broke at the mid portion of the catheter while advancing into the guide.The stent was pulled out from the guide catheter without removing the device from it.The procedure was completed with a different device.No patient complications were reported and the patient remained stable all throughout the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 48cm distal of the strain relief.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported broken shaft as the hypotube was separated.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9912491
• Report Number: 2134265-2020-03897
• Device Sequence Number: 3435269
• Product Code: LOX
• UDI-Device Identifier: 08714729846505
• UDI-Public: 08714729846505
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2021
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0024596638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention