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

Model Number	7132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The 75% stenosed target lesion was located in the non-tortuous and non-calcified circumflex artery.Following pre dilatation with a 2.50mm x 12mm emerge balloon catheter, an unknown stent was introduced but it could not be advanced and was removed.The emerge balloon was re-inserted and as it was being advanced, the shaft broke at the distal end proximal to the balloon portion.The balloon was removed safely and the procedure was completed with another of same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the returned product consisted of an emerge balloon catheter.The device was microscopically and visually examined.There were numerous kinks to the hypotube.There was contrast in the inflation lumen and balloon.There was blood in the inflation lumen and guidewire lumen.The balloon was loosely folded.At the exit notch moving distally towards the tip of the device, in the length of 48mm, both the guidewire lumen and inflation lumen were torn open and apart.The damage is consistent with damage likely due from difficulties removing or inserting the guidewire, handling damage during preparation, and use during the procedure or post procedure.
Event or Problem Description
It was reported that a shaft break occurred.The 75% stenosed target lesion was located in the non-tortuous and non-calcified circumflex artery.Following pre dilatation with a 2.50mm x 12mm emerge balloon catheter, an unknown stent was introduced but it could not be advanced and was removed.The emerge balloon was re-inserted and as it was being advanced, the shaft broke at the distal end proximal to the balloon portion.The balloon was removed safely and the procedure was completed with another of same 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
• MDR Report Key: 11735624
• Report Number: 2134265-2021-04900
• Device Sequence Number: 17251662
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: 08714729806103
• 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): 06/03/2021

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: 09/16/2023
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0026654827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1