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

Model Number	7134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a highly calcified and tortuous artery.A 2.25mm x 20mm emerge balloon catheter was selected for use.However, when tried to cross the lesion, it was noted that the hypotube was bent with force and the shaft broke.The break was outside the patient's body.No further 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 were numerous kinks.There was a complete separation at 51cm distal of the strain relief.There was contrast in the inflation lumen, and blood in the guidewire lumen.The balloon was tightly folded.Microscopic inspection revealed tip damage.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a highly calcified and tortuous artery.A 2.25mm x 20mm emerge balloon catheter was selected for use.However, when tried to cross the lesion, it was noted that the hypotube was bent with force and the shaft broke.The break was outside the patient's body.No further complications 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: 9124991
• Report Number: 2134265-2019-10801
• Device Sequence Number: 2819461
• Product Code: LOX
• UDI-Device Identifier: 08714729806318
• UDI-Public: 08714729806318
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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: 01/23/2022
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0023867049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1