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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, the shaft was noted to be broken after insertion and it is unclear if there was an attempt to inflate.The device was removed and there were no device fragments retained inside the patient's body.The procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was microscopically and visually examined.At 20cm from the strain relief, the hypotube of the device was kinked.There was a separation of the hypotube at 21.3cm from the strain relief.The separated ends were ovaled in shape indicating the device was kinked prior to separation.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Review of the media attached in the complaint record depicted a hypotube kink just proximal to the hypotube separation.The separation confirms the reported event, and the damage depicted in the media aligns to what was seen in device analysis.Product analysis confirmed the reported break as there was separation to the device.The device also had an unreported kink.
Event or Problem Description
It was reported that shaft break occurred.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, the shaft was noted to be broken after insertion and it is unclear if there was an attempt to inflate.The device was removed and there were no device fragments retained inside the patient's body.The procedure was completed with another of same device.There were no patient complications 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15258275
• Report Number: 2124215-2022-29127
• Device Sequence Number: 12415651
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: 08714729846529
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: 04/04/2024
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0029175384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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 Age: 83 YR
• Patient Sex: Male