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

Model Number	7212
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified aorto-ostial right coronary artery (rca).A 3.50 x 28mm synergy megatron drug-eluting stent was advanced for treatment.However, after initial deployment of the stent, interaction with the guide catheter caused axial deformation of the stent.As a result, subsequent post inflation ballooning was made difficult.A new wire was placed outside the first row of megatron stent struts and balloons were used in a "crush" technique to create an opening.Then, a new stent was deployed at the ostium rca and the procedure was successful.The patient then underwent angiogram of the target lesion located in the non-tortuous mid to distal right coronary artery.A 2.50mm x 12mm nc emerge was advanced and deployed for treatment.However, during withdrawal, the hypotube broke just proximal to the balloon and remained inside the patient.A new stent was placed to pin the balloon fragment onto another stent to avoid migration.No further patient complications were reported.
Event or Problem Description
It was reported that catheter entrapment occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified aorto-ostial right coronary artery (rca).A 3.50 x 28mm synergy megatron drug-eluting stent was advanced for treatment.However, after initial deployment of the stent, interaction with the guide catheter caused axial deformation of the stent.As a result, subsequent post inflation ballooning was made difficult.A new wire was placed outside the first row of megatron stent struts and balloons were used in a "crush" technique to create an opening.Then, a new stent was deployed at the ostium rca and the procedure was successful.The patient then underwent angiogram of the target lesion located in the non-tortuous mid to distal right coronary artery.A 2.50mm x 12mm nc emerge was advanced and deployed for treatment.However, during withdrawal, the hypotube broke just proximal to the balloon and remained inside the patient.A new stent was placed to pin the balloon fragment onto another stent to avoid migration.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter with an unknown 0.014 inches guidewire within the device.The device was visually and microscopically examined.There were numerous kinks to both the hypotube and shaft of the device.There was contrast in the inflation lumen and the balloon.There was a copious amount of blood within the guidewire lumen and the balloon was loosely folded.The unknown guidewire was shipped within the returned device, to which the wire was able to be removed without issue or irregularity.The undamaged portion of the guidewire was measured with a laser micrometer to measure the outer diameter which was 0.014 inches making the guidewire of compatible use according to instructions for use.The guidewire passed through device with no resistance or issues.The guidewire was inserted through both the rapid port exchange and the tip of the device and encountered no difficulties.Product analysis did not confirm the reported event, because the guidewire passed through the device with no resistance or issues.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17290587
• Report Number: 2124215-2023-34441
• Device Sequence Number: 6319514
• Product Code: LOX
• UDI-Device Identifier: 08714729846376
• UDI-Public: 08714729846376
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/25/2023

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: 04/04/2025
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0031370679
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2023
• 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
• Patient Sex: Unknown