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

Model Number	7130
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon incorrect size was encountered.The target lesion was located in the left anterior descending artery.A 3.50mm x 8mm emerge balloon catheter was advanced for dilation.However, during inflation, the balloon inflation protruded the markers.The balloon was removed and inflated outside the body at nominal pressure and it was noted that it over expanded.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge mr balloon catheter.The device was microscopically and visually examined.There was contrast in the inflation lumen and the balloon.The balloon was loosely folded, and there was a 7mm long longitudinal tear approximately 1mm proximal from the tip of device.There is a buckled guidewire lumen 1mm in length at the balloon transition approximately 2mm proximal from the tip of device.The overall length of the device was 142.1cm.The length of the distal end of the distal markerband to the proximal end of the proximal markerband was 8mm.The device could not be inflated to take an accurate measurement of the balloon due to device damage.The overall length of the device did meet product specification at 142.1cm.
Event or Problem Description
It was reported that balloon incorrect size was encountered.The target lesion was located in the left anterior descending artery.A 3.50mm x 8mm emerge balloon catheter was advanced for dilation.However, during inflation, the balloon inflation portruded the markers.The balloon was removed and inflated outside the body at nominal pressure and it was noted that it over expanded.The procedure was completed with another of the 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: 11653200
• Report Number: 2134265-2021-04199
• Device Sequence Number: 3658461
• Product Code: LOX
• UDI-Device Identifier: 08714729806561
• UDI-Public: 08714729806561
• 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: 08/07/2022
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 0024910728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 04/12/2021
• 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