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

Model Number H749RB4400100

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

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 Description

It was reported that a balloon rupture occurred.The target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery (rca).A 10/4.00 flextome¿ cutting balloon¿ was selected for use.During the procedure, at third inflation, it was noted that the balloon ruptured at 12atm.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual examination was performed on the returned flextome cb monorail device.The balloon was observed to be unfolded which indicates that the balloon had been subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied.The balloon could not be inflated due to the presence of solidified inflation medium within the balloon and inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the solidified inflation medium before further inflation attempts were made.On removal from the bath the returned device was again attached to encore inflation unit and positive pressure was applied when liquid was seen escaping from a pinhole leak in the balloon material at the proximal edge of the proximal markerband.No issues were identified with the balloon material that could have contributed to the complaint incident.A visual examination of the tip and markerbands identified no issues which could have potentially contributed to this complaint.Microscopic and visual analysis showed that the blades were intact and fully bonded to the balloon surface.Multiple kinks were observed along the hypotube of the device.This type of damage is consistent with excessive force being applied to the delivery system during device use.No other issues were identified during device analysis.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 target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery (rca).A 10/4.00 flextome¿ cutting balloon¿ was selected for use.During the procedure, at third inflation, it was noted that the balloon ruptured at 12atm.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.

• 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: 7131370
• MDR Text Key: 95344351
• Report Number: 2134265-2017-12645
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

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: 02/27/2020
• Device Model Number: H749RB4400100
• Device Catalogue Number: RB440010
• Device Lot Number: 0020336128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• 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