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

Model Number	7133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 3.00mm x 15mm emerge balloon catheter was selected for use.However, the device broke while introducing it in the guide catheter.There were no patient complications reported.No further information available.
Event or Problem Description
It was reported that shaft break occurred.A 3.00mm x 15mm emerge balloon catheter was selected for use.However, the device broke while introducing it in the guide catheter.There were no patient complications reported.No further information available.
Additional Manufacturer Narrative
Device evaluated by mfr.:returned product consisted of an emerge balloon catheter.The balloon was tightly folded.Microscopic examination revealed that the hypotube had numerous kinks.There were no separations identified.The reported separation was not returned.

• 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: 9455568
• Report Number: 2134265-2019-15604
• Device Sequence Number: 2431882
• Product Code: LOX
• UDI-Device Identifier: 08714729806233
• UDI-Public: 08714729806233
• Combination Product (Y/N): N
• Initial Reporter Country: RQ
• 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
• Report Date (Section B): 01/28/2020

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 Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0024185650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1