MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON®; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number M001PCB6020900

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: under 18 years.(b)(4).

Event Description

Same case as mdr id: 2134265-2017-12433.It was reported that the balloon was broken and the blade got detached.The target lesion was located in the pulmonary vein.A 7mmx 2cmx 90cm 2cm peripheral cutting balloon® and a 6mx 2cmx 90cm 2cm peripheral cutting balloon® were selected for use.During procedure, it was noted that the 7mm cutting balloon got broken upon deflation and was removed.Then a 6mm cutting balloon was then used.However, the blade of the balloon was noted to have fell off.The procedure was completed with another device.No patient complications were reported and patient's status was fine.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual and tactile examination of the shaft, balloon and marker bands was performed.The shaft was kinked at 56.4cm distal to the strain relief and the kink noted was consistent with excessive force having been applied to the shaft.An examination of the balloon noted a section of the blade and pad were lifted.This section extended from the proximal end of one of the blades to 12mm distal from the proximal end.Further examinations identified a 2mm width circumferential tear in the balloon material.The tear was located approximately 5mm proximal from the proximal edge of the distal markerband.No other damage was noted along the balloon.All other blades were fully intact and bonded to the balloon.An examination of the distal and proximal markerbands identified no issues.No other issues were identified during the product 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

Same case as mdr id: 2134265-2017-12433.It was reported that the balloon was broken and the blade got detached.The target lesion was located in the pulmonary vein.A 7mmx 2cmx 90cm 2cm peripheral cutting balloon and a 6mx 2cmx 90cm 2cm peripheral cutting balloon were selected for use.During procedure, it was noted that the 7mm cutting balloon got broken upon deflation and was removed.Then a 6mm cutting balloon was then used.However, the blade of the balloon was noted to have fell off.The procedure was completed with another device.No patient complications were reported and patient's status was fine.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON®
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• 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: 7122149
• MDR Text Key: 95519168
• Report Number: 2134265-2017-12434
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

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 Model Number: M001PCB6020900
• Device Catalogue Number: PCB602090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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