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

Model Number M001PCB6020900

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2015

Event Type  malfunction  

Event Description

It was reported that the blade was partially lifted.The stenosed target lesion was located in the arm.A 6.00mm/2.0cm/90cm peripheral cutting balloon® was selected for fistulagram.During procedure, after a single inflation, the physician took the balloon from the sheath.It was noted that a portion of the cutter was partially lifted and was hanging off the balloon.The procedure was completed with this device.No patient complications were reported and the patient's status was fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer.The device was returned for analysis.A visual examination identified that 5 mm of one blade and blade pad had lifted from the balloon's proximal body.However, 3.5 mm of the proximal section of the blade pad was still intact.The remaining blades were fully bonded to the balloon and no damage was noted to the other blades and to the tip.It was also noted that the balloon was not folded which subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The device was attached to an encore inflation unit.Positive pressure was applied when a leak was noted.A further microscopic analysis noted a pinhole at 5 mm distal to the distal end of the proximal markerband.No further damage was noted to the catheter.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that the blade was partially lifted.The stenosed target lesion was located in the arm.A 6.00mm/2.0cm/90cm peripheral cutting balloon® was selected for fistulogram.During procedure, after a single inflation, the physician took the balloon from the sheath.It was noted that a portion of the cutter was partially lifted and was hanging off the balloon.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; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4480568
• MDR Text Key: 15966651
• Report Number: 2134265-2015-00181
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2016
• Device Model Number: M001PCB6020900
• Device Catalogue Number: PCB602090
• Device Lot Number: 0017401319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2014
• 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