MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	3820
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Cardiopulmonary Arrest (1765); No Code Available (3191)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon lodged in patient's artery and patient complications occurred.A 06/3.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon became lodged in the patient's left main artery.The patient had very heavy calcium in the left anterior descending artery (lad) to left main (lm).These vessels were not stented; however, the circumflex was stented to the bifurcation.The patient was coded on the table and an impella was placed to help stabilize the patient.The patient was rushed to open heart surgery and does not have a good chance of surviving.

• Brand Name: FLEXTOME CUTTING BALLOON
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7842621
• Report Number: 2134265-2018-60593
• Device Sequence Number: 16629342
• Product Code: NWX
• UDI-Device Identifier: 08714729808268
• UDI-Public: 08714729808268
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• 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
• Report Date (Section B): 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2019
• Device Model Number: 3820
• Device Catalogue Number: 3820
• Device Lot Number: 0020038214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 69 YR