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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that shaft break occurred.A 2.75mm x 15mm emerge balloon catheter was advanced for treatment.During an attempted angioplasty, the physician loaded device on wire and advanced through the guide to treat the vessel.About halfway through the guide, the catheter snapped in two.No further information was reported.
Event or Problem Description
It was reported that shaft break occurred.A 2.75mm x 15mm emerge balloon catheter was advanced for treatment.During an attempted angioplasty, the physician loaded device on wire and advanced through the guide to treat the vessel.About halfway through the guide, the catheter snapped in two.No further information was reported.It was further reported that the device broke just outside the guide and the procedure was completed with another emerge balloon catheter.
Additional Manufacturer Narrative
(b3) date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that shaft break occurred.A 2.75mm x 15mm emerge balloon catheter was used for treatment.During an attempted angioplasty, the physician loaded device on wire and advanced thourgh the guide to treat the vessel.About halfway through the guide was advanced, the catheter snapped into two.No further information was reported.It was further reported that the device broke just outside the guide and the procedure was completed with another emerge balloon catheter.
Additional Manufacturer Narrative
(b3) date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: returned device consisted of an emerge mr balloon catheter in two pieces.The balloon was tightly folded.Analysis of the tip, inner/outer shaft, hypotube and hub included microscopic and visual inspection.Inspection revealed a complete separation in the hypotube, and there were numerous kinks in the hypotube.The fracture faces were ovalized, as if kinked prior to separating.Inspection of the device found no other damage or defects.

• 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: 10254882
• Report Number: 2134265-2020-08461
• Device Sequence Number: 19477354
• Product Code: LOX
• UDI-Device Identifier: 08714729806226
• UDI-Public: 08714729806226
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 09/01/2020

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: 08/09/2022
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0024924838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 07/06/2020; 08/11/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/24/2020; 09/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1