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

Model Number	7133
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in left anterior descending artery.A 2.00mm x 15mm emerge balloon catheter was selected for dilatation.However, during preparation, a balloon pinhole was noted.The procedure was completed with a non-bsc device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was visually and microscopically examined.There was contrast in the inflation lumen and the balloon was tightly folded.At 2mm distal to the bicomponent weld of the device, for a length of 2mm, the guidewire lumen was punctured, buckled, and prolapsed.Product analysis could not confirm reported burst.Further functional testing, such as inflation of the device, could not be performed to test the balloon as the guidewire lumen puncture would prevent the device from inflation.Analysis shows the guidewire lumen was buckled, prolapsed, and punctured which is consistent with an interaction with a guidewire during procedural use.
Event or Problem Description
It was reported that balloon pinhole occurred.The target lesion was located in left anterior descending artery.A 2.00mm x 15mm emerge balloon catheter was selected for dilatation.However, during preparation, a balloon pinhole was noted.The procedure was completed with a non-bsc device.There were no patient complications nor injuries reported.

• Brand Name: 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16326175
• Report Number: 2124215-2023-05261
• Device Sequence Number: 15414956
• Product Code: LOX
• UDI-Device Identifier: 08714729806196
• UDI-Public: 08714729806196
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/21/2023

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: 01/05/2025
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0029379744
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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