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

Model Number	7130
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.After a critical vessel was fixed, a 2.00mm x 8mm emerge balloon catheter was introduced to fix a less urgently stenotic vessel.The balloon catheter was advanced halfway through a 6fr guide catheter and became stuck.The device was pulled back and during another advancing attempt, the hypotube snapped in half approximately 70cm from the hub.The device was successfully removed along with the catheters and the procedure was terminated.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.After a critical vessel was fixed, a 2.00mm x 8mm emerge balloon catheter was introduced to fix a less urgently stenotic vessel.The balloon catheter was advanced halfway through a 6fr guide catheter and became stuck.The device was pulled back and during another advancing attempt, the hypotube snapped in half approximately 70cm from the hub.The device was successfully removed along with the catheters and the procedure was terminated.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was a complete separation at 59.5cm distal of the strain relief.There was contrast and blood in the inflation lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 11440363
• Report Number: 2134265-2021-02237
• Device Sequence Number: 3618706
• Product Code: LOX
• UDI-Device Identifier: 08714729806509
• UDI-Public: 08714729806509
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/14/2021

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: 03/17/2023
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 0025737580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1