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

Model Number	7132
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device break occurred.A 90% stenosed target lesion was located in the severely tortuous and severely calcified proximal circumflex coronary and diagonal resistant lesion.The physician wired the vessel and attempted to balloon the circumflex.The lesion did not expand.A 1.50mm rotapro was selected for atherectomy.After two passes, the 1.50mm rotapro was removed.The physician wired the diagonal lesion.A 1.25mm rotapro burr was advanced.Atherectomy was performed.A large perforation was noted after using the 1.25mm rotapro burr.The physician tamponade the vessel with a balloon and a stent was deployed to cover the perforation but it was unable to get to area.The physician repositioned the 2.00mm x 12mm emerge balloon.There was difficulty removing the balloon.The balloon pulled apart at the distal to the inner connection.The emerge balloon and guidewire were removed together as one unit from the patient.The guidewire was able to be removed from the emerge once outside the patient.The patient died post.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an emerge mr balloon catheter.A visual examination shows that there were numerous hypotube and shaft kinks.The inflation lumen was separated and stretched at 115.7cm from the strain relief.The total distal length of the separation was 49.2cm from the separation to the tip of the device.There was contrast in the inflation lumen and the balloon.There was blood in the inflation lumen and guidewire lumen.The covered non-boston scientific stent was returned with the device and not in place on the balloon but on the shaft and moveable.There was stent damage to the proximal of the stent.The cover prevented further analysis of the stent.The balloon was loosely folded, and the distal portion of the balloon was prolapsed.There was tip damage to the device.The inflation lumen was stretched and separated, and the balloon was prolapsed indicating there were difficulties in the process of removal.Inspection of the remainder of the device, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the device break occurred.A 90% stenosed target lesion was located in the severely tortuous and severely calcified proximal circumflex coronary and diagonal resistant lesion.The physician wired the vessel and attempted to balloon the circumflex.The lesion did not expand.A 1.50mm rotapro was selected for atherectomy.After two passes, the 1.50mm rotapro was removed.The physician wired the diagonal lesion.A 1.25mm rotapro burr was advanced.Atherectomy was performed.A large perforation was noted after using the 1.25mm rotapro burr.The physician tamponade the vessel with a balloon and a stent was deployed to cover the perforation but it was unable to get to area.The physician repositioned the 2.00mm x 12mm emerge balloon.There was difficulty removing the balloon.The balloon pulled apart at the distal to the inner connection.The emerge balloon and guidewire were removed together as one unit from the patient.The guidewire was able to be removed from the emerge once outside the patient.The patient died post.

• 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: 12459697
• Report Number: 2134265-2021-11521
• Device Sequence Number: 4067396
• Product Code: LOX
• UDI-Device Identifier: 08714729806080
• UDI-Public: 08714729806080
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/14/2021

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: 12/01/2023
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0027081921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1