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	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in mildly calcified mid left anterior descending artery.Two 2.50mm x 15mm nc emerge balloon catheters were used for dilatation.However, upon insertion, both devices were fractured prior to crossing the lesion.It was noted that the first device broke closer to the wire exit port and the other device broke closer to the hub.The devices were removed and no fragments left inside the patient's body.The procedure was completed with a 2.5x15 non-boston scientific stent.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.The 80% stenosed target lesion was located in mildly calcified mid left anterior descending artery.Two 2.50mm x 15mm nc emerge balloon catheters were used for dilatation.However, upon insertion, both devices were fractured prior to crossing the lesion.It was noted that the first device broke closer to the wire exit port and the other device broke closer to the hub.The devices were removed and no fragments left inside the patient's body.The procedure was completed with a 2.5x15 non-boston scientific stent.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 visually and microscopically examined.At 30.8cm from the strain relief, the hypotube of the device was kinked.At 34cm from the strain relief, the hypotube was separated.The separated ends were ovaled in shape indicating the device was kinked prior to separation.At 2.3cm, and 3cm distal from the separation, the hypotube was kinked.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded, and the device had tip damage.Photo media depicted the sizing on the hub as well as a hypotube kink, and a hypotube separation just proximal to the kink.The kink and separation aligned with what was seen in analysis and confirmed the reported separation.Product analysis confirmed the reported break as there was separation to the device.The device also had unreported hypotube kinks and tip damage.Photo media aligned with the reported events and confirmed the reported separation.

• 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: 15217702
• Report Number: 2124215-2022-29926
• Device Sequence Number: 12440201
• Product Code: LOX
• UDI-Device Identifier: 08714729846505
• UDI-Public: 08714729846505
• 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): 09/22/2022

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: 02/23/2024
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0028922004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• 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: 78 YR
• Patient Sex: Female