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

Model Number	7213
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 05-apr-2022.It was reported that balloon inflation failure occurred.A 2.25mm x 15mm nc emerge balloon catheter was advanced for dilatation.However, during the procedure, the balloon failed to inflate.The procedure was completed with another of the same device.There were no complications reported and the patient was stable.However, returned device analysis revealed shaft break.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was microscopically and visually examined.There were numerous kinks to the hypotube.There was a separation in the hypotube at 17.3cm from the strain relief.The separated ends of the hypotube were oval shaped indicating that the device was kinked prior to separation.There was contrast in the inflation lumen and the balloon.The balloon was loosely folded.From the separation, the distal end of the device was connected to a touhy and prepped with an inflation device filled with water to inflate the device.The balloon was able to be inflated to rated burst pressure, as well as deflate with no issues.Product analysis could not confirm the reported event, as during functional testing the balloon inflated to rated burst pressure and deflated with no issues.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14132244
• Report Number: 2134265-2022-04208
• Device Sequence Number: 14026171
• Product Code: LOX
• UDI-Device Identifier: 08714729846499
• UDI-Public: 08714729846499
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2022

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: 10/04/2023
• Device Model Number: 7213
• Device Catalogue Number: 7213
• Device Lot Number: 0028133153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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