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

Model Number	7143
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation issue occurred.A 1.20mm x 15mm emerge balloon catheter was selected for use; however, deflation issues were noted.The procedure was completed with no patient complications nor injuries reported.
Additional Manufacturer Narrative
H6: evaluation result codes: updated the device was not returned for analysis.Since the balloon has to be used before the expiration date specified on the package and it was confirmed based on the information given, that the balloon was used later, this indicates a failure to follow instructions.Therefore, based on the evidence, the most probable cause for the reported failed to deflate was considered failure to follow instructions.
Event or Problem Description
It was reported that balloon deflation issue occurred.A 1.20mm x 15mm emerge balloon catheter was selected for use; however, deflation issues were noted.The procedure was completed with no patient complications nor injuries 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: 18619451
• Report Number: 2124215-2024-02488
• Device Sequence Number: 2405832
• Product Code: LOX
• UDI-Device Identifier: 08714729806783
• UDI-Public: 08714729806783
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K130391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: 10/22/2023
• Device Model Number: 7143
• Device Catalogue Number: 7143
• Device Lot Number: 0028250331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• 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