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

Model Number M001PCB5020900

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 old.(b)(4).

Event Description

It was reported that the blade was partially detached.The target lesion was located in the mildly tortuous and moderately calcified pulmonary vein.A 2cm peripheral cutting balloon® was selected for use.During the procedure, a non bsc sheath was used with the 2cm peripheral cutting balloon® and went over a thruway 0.18 wire.When the balloon came out of the non bsc sheath, it was noted that the blade almost came off.The procedure was completed with this device.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination of the device identified that 6mm of one of the blades and pads was partially detached from the proximal end of the balloon material.The remaining section of blade and pad were noted to be fully attached to the balloon material.All other blades were intact and fully bonded to the balloon surface.The balloon was unfolded which indicates it had been subjected to positive pressure.An examination of the balloon material identified no issues.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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 the blade was partially detached.The target lesion was located in the mildly tortuous and moderately calcified pulmonary vein.A 2cm peripheral cutting balloon was selected for use.During the procedure, a non bsc sheath was used with the 2cm peripheral cutting balloon and went over a thruway 0.18 wire.When the balloon came out of the non bsc sheath, it was noted that the blade almost came off.The procedure was completed with this device.No patient complications were reported and the 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: 7122174
• MDR Text Key: 95059204
• Report Number: 2134265-2017-12432
• 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

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2019
• Device Model Number: M001PCB5020900
• Device Catalogue Number: PCB502090
• Device Lot Number: 21194390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2017
• 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