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

Model Number	7135
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event - used the first day of the month of the bsc aware date.Event date not provided.
Event or Problem Description
It was reported that ro marker band misalignment occurred.A 2.50mm x 30mm emerge balloon catheter was advanced for treatment.However, during inflation at 18 atmospheres, it was noted that the markers are not accurate as emerge balloon edge extends well past marker.There were no patient complications nor injuries reported.No further information available.
Additional Manufacturer Narrative
(b3) date of event: corrected to (b)(6) 2020.
Event or Problem Description
It was reported that ro marker band misalignment occurred.A 2.50mm x 30mm emerge balloon catheter was advanced for treatment.However, during inflation at 18 atmospheres, it was noted that the markers are not accurate as emerge balloon edge extends well past marker.There were no patient complications nor injuries reported.No further information available.It was further reported that the target lesion was 80% stenosed located in the non-tortuous and mildly calcified mid left anterior descending artery.Following pre-dilatation, a non-bsc stent was deployed and completed the procedure.There were no patient complications reported and the patient's status was good.
Event or Problem Description
It was reported that ro marker band misalignment occurred.A 2.50mm x 30mm emerge balloon catheter was advanced for treatment.However, during inflation at 18 atmospheres, it was noted that the markers are not accurate as emerge balloon edge extends well past marker.There were no patient complications nor injuries reported.No further information available.It was further reported that the target lesion was 80% stenosed located in the non-tortuous and mildly calcified mid left anterior descending artery.Following pre-dilatation, a non-bsc stent was deployed and completed the procedure.There were no patient complications reported and the patient's status was good.
Additional Manufacturer Narrative
(b3) date of event: corrected from (b)(6) 2020 to (b)(6) 2020.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 contrast in the inflation lumen and balloon.The balloon was loosely folded.The device was soaked in a water bath for five days to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.The device was unable to be inflated as there was a tear on the shaft 26.6cm from the tip.The marker bands were 30mm apart, the distal marker band was 2mm from the distal end of the balloon, and the proximal marker band was 2mm from the proximal end of the balloon.There were no indications of marker band damage, or that the marker bands had moved.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: 9818957
• Report Number: 2134265-2020-02610
• Device Sequence Number: 16531912
• Product Code: LOX
• UDI-Device Identifier: 08714729806417
• UDI-Public: 08714729806417
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2020

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: 07/08/2022
• Device Model Number: 7135
• Device Catalogue Number: 7135
• Device Lot Number: 0024745352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/24/2020; 04/23/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/16/2020; 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1