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

Model Number	7135
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal to mid left anterior descending artery.A 2.00mm x 30mm emerge balloon catheter was introduced for dilatation.However, as the device was being advanced into the lesion, the shaft broke outside the patient at approximately 6 inches from the hub.The device was removed and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
The returned product consisted of an emerge mr balloon catheter.The device was microscopically and visually examined.There was a separation of the hypotube 20.7cm from the strain relief.There were numerous kinks.There was contrast in the inflation lumen.The balloon was tightly folded with blood and contrast in the balloon folds.There was tip damage to the device.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified proximal to mid left anterior descending artery.A 2.00mm x 30mm emerge balloon catheter was introduced for dilatation.However, as the device was being advanced into the lesion, the shaft broke outside the patient at approximately 6 inches from the hub.The device was removed and the procedure was completed with a different device.No patient 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: 11966595
• Report Number: 2134265-2021-07401
• Device Sequence Number: 14246132
• Product Code: LOX
• UDI-Device Identifier: 08714729806394
• UDI-Public: 08714729806394
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 07/08/2021

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: 09/23/2023
• Device Model Number: 7135
• Device Catalogue Number: 7135
• Device Lot Number: 0026695643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1