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

Model Number H749RB4300100

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).The device was not be returned for evaluation.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that a balloon rupture occurred.The concentric, de novo target lesion was located in the mildly calcified coronary artery.A 10/3.00 flextome¿ cutting balloon¿ was selected for use.During the procedure, the balloon burst when it was inflated.The procedure was completed with another of the same device.No patient complications were reported and patient status is stable.

• Brand Name: FLEXTOME¿ CUTTING BALLOON¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7139810
• MDR Text Key: 95664002
• Report Number: 2134265-2017-13008
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2020
• Device Model Number: H749RB4300100
• Device Catalogue Number: RB430010
• Device Lot Number: 0020671936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1