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

Model Number	7132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a vessel in the left ventricle.A 1.20mmx12mm emerge balloon catheter was advanced for dilatation.However, it was noted that the balloon was fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube, balloon, and guidewire lumen.The hypotube is separated 66.8cm from the hub and appears to have been kinked prior to separation.Microscopic examination revealed no additional damages.There is blood present in the guidewire lumen and the balloon is loosely folded.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 vessel in the left ventricle.A 1.20mmx12mm emerge balloon catheter was advanced for dilatation.However, it was noted that the balloon was fractured.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

• 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: 8486841
• Report Number: 2134265-2019-03514
• Device Sequence Number: 2689707
• Product Code: LOX
• UDI-Device Identifier: 08714729806066
• UDI-Public: 08714729806066
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130391
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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: 11/08/2020
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0021860239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 64