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

Model Number	7134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The proximal shaft broke on a 2.00mm x 20mm emerge balloon catheter during preparation.The procedure was completed with a different device.No further complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge mr balloon catheter.The device was microscopically and visually examined.The stopcock was still attached to the device upon return.There were numerous severe hypotube kinks to the device.At 37cm from the strain relief the hypotube was separated.The separated ends were ovaled in shape indicating the device was kinked prior to separation.There was contrast and blood present in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Product analysis confirmed the reported break as there was separation of the device.There were also numerous unreported kinks.
Event or Problem Description
It was reported that shaft break occurred.The proximal shaft broke on a 2.00mm x 20mm emerge balloon catheter during preparation.The procedure was completed with a different device.No further complications were 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
• MDR Report Key: 12188174
• Report Number: 2134265-2021-09210
• Device Sequence Number: 3509762
• Product Code: LOX
• UDI-Device Identifier: 08714729806301
• UDI-Public: 08714729806301
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: 01/09/2024
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0027313546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1