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

Model Number	7212
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device sterility was compromised.During preparation of a 3.50mm x 12mm nc emerge balloon catheter, it was noticed that there was a handwritten note on the back of the internal sterilized packaging.The device was not used and the procedure was completed with another of the same device.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The product packaging was visually examined.The pouch had been opened and a device and compliance chart were inside.The compliance chart had writing on the back.No other issues or damage were found on the pouch, carton, or device.The complaint investigation conclusion code is manufacturing deficiency as problems traced to manufacturing process.Further internal investigation is being completed to address this issue.
Event or Problem Description
It was reported that device sterility was compromised.During preparation of a 3.50mm x 12mm nc emerge balloon catheter, it was noticed that there was a handwritten note on the back of the internal sterilized packaging.The device was not used and the procedure was completed with another of the same device.

• 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: 9111484
• Report Number: 2134265-2019-10863
• Device Sequence Number: 2862627
• Product Code: LOX
• UDI-Device Identifier: 08714729846413
• UDI-Public: 08714729846413
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 10/22/2019

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 Expiration Date: 06/12/2021
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0023946193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1