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

Model Number	7132
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that failure to deflate occurred.A 3.50mm x 12mm emerge balloon catheter was advanced for dilation.However, after the balloon was inflated, normal deflated did not occur.Manual deflation with syringe was made and the balloon, guide, and wire was removed.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg emerge mr, us 3.50mm x 12mm balloon catheter was returned to the complaint investigation site (cis).A visual and tactile examination identified multiple hypotube kinks along the length of the hypotube shaft.A break in midshaft at 119.5cm distal to the distal end of the strain relief was identified.The remainder of the distal section of the device was not returned.The reported allegation of balloon failure to deflate could not be confirmed as functional testing could not be performed on the partially returned device.
Event or Problem Description
It was reported that failure to deflate occurred.A 3.50mm x 12mm emerge balloon catheter was advanced for dilation.However, after the balloon was inflated, normal deflated did not occur.Manual deflation with syringe was made and the balloon, guide, and wire was removed.The procedure was completed with a different device.There were no patient complications reported.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19690785
• Report Number: 2124215-2024-39056
• Device Sequence Number: 8122420
• Product Code: LOX
• UDI-Device Identifier: 08714729806141
• UDI-Public: 08714729806141
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 09/12/2024

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: 07/03/2026
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0032759308
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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