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

Model Number	H749CBM3375060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2017-11159.It was reported that catheter break occurred and the patient was hurt.The target area was located in the lower right extremity.A 06/3.75 flextome® cutting balloon® and a 10/3.75 flextome® cutting balloon® were selected for use.During the procedure, it was observed that both cutting balloons broke into two pieces on the field.There was a point in the procedure where an incident hurt the patient.The procedure was completed with a different device.No further patient complications were reported and the patient's status was fine.

• Brand Name: FLEXTOME® CUTTING BALLOON®
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7042651
• Report Number: 2134265-2017-11158
• Device Sequence Number: 13932217
• Product Code: NWX
• UDI-Device Identifier: 08714729808299
• UDI-Public: 08714729808299
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/25/2017

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: 12/01/2018
• Device Model Number: H749CBM3375060
• Device Catalogue Number: CBM337506
• Device Lot Number: 0018690515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/17/2017
• 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: Other
• Patient Age: 69 YR