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

Model Number	7134
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.The patient was being treated for atherosclerosis and underwent heart catheterization.A 2.50mm x 20mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the balloon failed to inflate.The procedure was cancelled or rescheduled.No patient complications were reported.
Additional Manufacturer Narrative
E1: (b)(6).E3: occupation: updated from other health care professional to physician.
Event or Problem Description
It was reported that the procedure was cancelled.The patient was being treated for atherosclerosis and underwent heart catheterization.A 2.50mm x 20mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the balloon failed to inflate.The procedure was cancelled or rescheduled.No patient complications were reported.It was further reported that no visible pinhole was noted on the balloon material and the patient condition was stable post-procedure.
Event or Problem Description
It was reported that the procedure was cancelled.The patient was being treated for atherosclerosis and underwent heart catheterization.A 2.50mm x 20mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the balloon failed to inflate.The procedure was cancelled or rescheduled.No patient complications were reported.It was further reported that no visible pinhole was noted on the balloon material and the patient condition was stable post-procedure.
Additional Manufacturer Narrative
This supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgements from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.E1: initial reporter title and fax: updated.E1: initial reporter first name: (b)(6).E1: initial reporter last name: (b)(6).E3: occupation: updated from other health care professional to physician.Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was microscopically and visually examined.There were numerous kinks to the hypotube.There was a separation in the hypotube at 51.6cm 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 and blood in the inflation lumen and the balloon.There was blood in the guidewire lumen and 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: 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16449552
• Report Number: 2124215-2023-07754
• Device Sequence Number: 5872272
• Product Code: LOX
• UDI-Device Identifier: 08714729806325
• UDI-Public: 08714729806325
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• 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): 04/21/2023

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: 04/15/2025
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0029983170
• 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: 02/13/2023
• Supplement Date Received by Manufacturer: 02/24/2023; 03/15/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 03/09/2023; 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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 Sex: Unknown