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

Model Number	7142
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft perforation occurred.The target lesion was located in the mid left anterior descending artery.A 2.50mm x 12mm emerge balloon catheter was advanced for dilatation.However, when the balloon catheter was backloaded on the guidewire, the guidewire poked out of the side of the catheter.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft perforation occurred.The target lesion was located in the mid left anterior descending artery.A 2.50mm x 12mm emerge balloon catheter was advanced for dilatation.However, when the balloon catheter was backloaded on the guidewire, the guidewire poked out of the side of the catheter.The procedure was completed with another of the same device.There were no patient complications 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 was contrast in the inflation lumen.The balloon was loosely folded.Microscopic inspection revealed a hole in the inner shaft at 48mm proximal from the proximal marker band and a hole in the outer shaft at 50mm proximal from the proximal marker band.There was also tip damage.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: 8677121
• Report Number: 2134265-2019-05955
• Device Sequence Number: 11308344
• Product Code: LOX
• UDI-Device Identifier: 08714729806714
• UDI-Public: 08714729806714
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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: 03/07/2021
• Device Model Number: 7142
• Device Catalogue Number: 7142
• Device Lot Number: 0023456749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1