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

Model Number	7211
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that incorrect labeling occurred.The target lesion was located in the left main artery.A 5.00mm x 8mm nc emerge balloon catheter was advanced for dilatation.However, during inflation under radiography, it was noted that the size of the device was more than what the package label indicated.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.The device was returned with a carton and pouch.The labeling on the hub, pouch, and carton all matched.There were numerous kinks.There was contrast in the inflation lumen, and blood in the guidewire lumen.The balloon was tightly folded.The marker bands on the device were measured at 8mm from the proximal end to the distal end.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The balloon was measured after inflation and the distance between the cone transitions was 8mm.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not confirm the reported incorrect device.
Event or Problem Description
It was reported that incorrect labeling occurred.The target lesion was located in the left main artery.A 5.00mm x 8mm nc emerge balloon catheter was advanced for dilatation.However, during inflation under radiography, it was noted that the size of the device was more than what the package label indicated.The device was completely removed and the procedure was completed with another of the same device.No patient complications were reported and patient status was stable.

• 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: 9222003
• Report Number: 2134265-2019-12602
• Device Sequence Number: 2158095
• Product Code: LOX
• UDI-Device Identifier: 08714729846321
• UDI-Public: 08714729846321
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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
• Operator of Device: Health Professional
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0023086455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 09/29/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 66