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

Model Number	H7493926720250
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon issued occurred requiring additional intervention.The occluded target lesion was located in the mildly tortuous and calcified posterior tibial artery.After left leg angio was performed, there was a residual area of calcific non-expansion.A 2.50 x 20mm nc emerge balloon was advanced to post-dilate a stent.While in the distal superficial femoral artery, the balloon ruptured at 18 atmospheres and split in half, leaving behind the distal radiopaque tip of the balloon which embolized in a small geniculate branch off the knee.Another balloon was used to restore flow but an attempt to snare the detached piece was not successful.The patient fully recovered.
Additional Manufacturer Narrative
E1: initial reporter address (b)(6).
Additional Manufacturer Narrative
The fg nc emerge mr, us 2.50mm x 20mm was returned for analysis.Visual/tactile inspection revealed multiple hypotube kinks and that the inner lumen was detached at 19.2 cm starting from the ports exchange to the circumferential tear.Microscopic inspection of the balloon showed a circumferential tear in the distal section with the tip detached starting at 12mm from the proximal balloon cone.The tip showed no signs of damage.
Event or Problem Description
It was reported that a balloon issued occurred requiring additional intervention.The occluded target lesion was located in the mildly tortuous and calcified posterior tibial artery.After left leg angio was performed, there was a residual area of calcific non-expansion.A 2.50 x 20mm nc emerge balloon was advanced to post-dilate a stent.While in the distal superficial femoral artery, the balloon ruptured at 18 atmospheres and split in half, leaving behind the distal radiopaque tip of the balloon which embolized in a small geniculate branch off the knee.Another balloon was used to restore flow but an attempt to snare the detached piece was not successful.The patient fully recovered.
Event or Problem Description
It was reported that a balloon issued occurred requiring additional intervention.The occluded target lesion was located in the mildly tortuous and calcified posterior tibial artery.After left leg angio was performed, there was a residual area of calcific non-expansion.A 2.50 x 20mm nc emerge balloon was advanced to post-dilate a stent.While in the distal superficial femoral artery, the balloon ruptured at 18 atmospheres and split in half, leaving behind the distal radiopaque tip of the balloon which embolized in a small geniculate branch off the knee.Another balloon was used to restore flow but an attempt to snare the detached piece was not successful.The patient fully recovered.
Additional Manufacturer Narrative
Correction: h6 patient codes.This report was amended to update international medical device regulators forum (imdrf) codes.Incomplete coding of this event was identified during a retrospective review of complaints associated with capa-8580, which focused on identifying and remediating incomplete coding of events.Device analysis results: device technical analysis: the device was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.Examination of the balloon material identified a circumferential tear in the distal section with the tip detached.The inner lumen was detached at 19.2cm starting from port exchange to the circumferential tear.Additionally, multiple hypotube kinks were noted along the length of the hypotube shaft.No other device issues were identified during returned product analysis.Device history review: it was confirmed that this device met manufacturing specification prior to distribution and there are no manufacturing deviations which could have contributed to the reported event.Labeling review: there is evidence that the device was used in a manner inconsistent with the labelled indications.As per the intended use/indication for use3 included in the instructions for use: the nc emerge otw and nc emerge mr ptca dilatation catheters are indicated for the balloon catheter dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion in patients with atherosclerosis.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a conclusion code of cause traced to intentional off-label, unapproved, or contraindicated use.This code was selected as the most probable complaint cause based on the information available.It was reported the target lesion was located in the left posterior tibial artery and therefore cause traced to intentional off-label, unapproved, or contraindicated use is selected for the material rupture, device detachments, foreign body embolism and unretrieved fragment, illness and additional device required allegations.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 19817653
• Report Number: 2124215-2024-44864
• Device Sequence Number: 15600648
• Product Code: LOX
• UDI-Device Identifier: 08714729846635
• UDI-Public: 08714729846635
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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,Followup
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/22/2025
• Device Model Number: H7493926720250
• Device Catalogue Number: H7493926720250
• Device Lot Number: 0032274969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 09/13/2024; 03/13/2026
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/23/2024; 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown