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

Model Number	7212
Medical Device Problem Codes	Material Puncture/Hole (1504); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date since event date was not provided.
Event or Problem Description
It was reported that shaft hole occurred.A 3.25mm x 12mm nc emerge balloon catheter was selected for dilation.However, the wire would not feed through the balloon shaft when the balloon was tried to load on the wire and a shaft hole was noted.The device was replaced with a new nc emerge balloon catheter and the procedure was completed successfully.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
B3 date of event: used the first day of the month of the bsc aware date since event date was not provided.Returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was contrast present in the inflation lumen.The guidewire lumen was buckled and prolapsed 2mm distal from the bicomponent weld, at 1mm in length.Within this buckle were two punctures in the lumen indicative to an interaction with a guidewire.At 5mm distal from the bicomponent weld, for a length of 1mm, the guidewire lumen was buckled and prolapsed, without signs of puncture, for a second segment.The balloon had tight folds.Further inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft hole occurred.A 3.25mm x 12mm nc emerge balloon catheter was selected for dilation.However, the wire would not feed through the balloon shaft when the balloon was tried to load on the wire and a shaft hole was noted.The device was replaced with a new nc emerge balloon catheter and the procedure was completed successfully.There were no patient complications nor injuries reported.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15554528
• Report Number: 2124215-2022-39718
• Device Sequence Number: 12387463
• Product Code: LOX
• UDI-Device Identifier: 08714729846406
• UDI-Public: 08714729846406
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: 11/30/2023
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0028469743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown