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

Model Number	7214
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deflation failure which requires additional device.The 90% stenosed target lesion was located in the circumflex coronary artery.A 3.00mm x 20mm fg nc emerge balloon catheter was advanced for dilation.The balloon was inflated to 16 atmospheres, however; it would not deflate initially.Physician pulled negative twice and then had to use syringe to manually deflate for two minutes in order to get the balloon back into the guide.The procedure was completed with a different 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 visually and microscopically examined.There was contrast and blood in the inflation lumen and the balloon.There was blood in the guidewire lumen and the balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the calibrated pressure gage to inflate the device.The device inflated to rated burst pressure and deflated with no issue or irregularity.
Event or Problem Description
It was reported that deflation failure which requires additional device.The 90% stenosed target lesion was located in the circumflex coronary artery.A 3.00mm x 20mm fg nc emerge balloon catheter was advanced for dilation.The balloon was inflated to 16 atmospheres, however; it would not deflate initially.Physician pulled negative twice and then had to use syringe to manually deflate for two minutes in order to get the balloon back into the guide.The procedure was completed with a different 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; 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: 17861761
• Report Number: 2124215-2023-51206
• Device Sequence Number: 20266265
• Product Code: LOX
• UDI-Device Identifier: 08714729846659
• UDI-Public: 08714729846659
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/07/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2025
• Device Model Number: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0031712856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2023
• 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