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

Model Number 7313

Device Problems Material Rupture (1546); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2019

Event Type  malfunction  

Event Description

It was reported that balloon tear occurred.The 85% stenosed target lesion was located in the mid left anterior descending artery.A 5.00 mm x 15 mm nc emerge balloon catheter was selected for dilatation.However, during the procedure, the balloon was noted to be torn.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.

Event Description

It was reported that balloon tear occurred.The 85% stenosed target lesion was located in the mid left anterior descending artery.A 5.00mm x 15mm nc emerge balloon catheter was selected for dilatation.However, during the procedure, the balloon was noted to be torn.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.

Manufacturer Narrative

Initial reporter city: (b)(6).Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon.The balloon was folded loosely.Microscopic inspection revealed tip damage.The device was soaked in a water bath for five days to loosen the blood and contrast in the device.A longitudinal tear 1.5mm long was detected 1mm proximal from the distal marker band.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: NC EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8638378
• MDR Text Key: 146059908
• Report Number: 2134265-2019-05706
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

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 Expiration Date: 07/23/2020
• Device Model Number: 7313
• Device Catalogue Number: 7313
• Device Lot Number: 0022418043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR