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

Model Number M001PCB6020900

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2014

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(4) 2014.It was reported that a bent blade occurred.The target lesion was located in a vessel in the right arm.A 6.00mm/2.0cm/90cm peripheral cutting balloon otw was used to treat the target lesion.After it was withdrawn, it was noted that one of the balloon blades was bent backwards.Procedure was completed with this device.There were no patient complications reported and the patient's status is fine.However, device analysis revealed that a proximal section of a blade was lifted.

Manufacturer Narrative

Device evaluated by manufacturer: device was returned for analysis.A visual examination of the returned unit confirmed that the proximal section of a blade was lifted and bent distally.No sections of the blade were detached.A balloon tear was noted at the site of the blade lifting.No further damage was noted to the catheter.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3932708
• MDR Text Key: 21732187
• Report Number: 2134265-2014-03987
• 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
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• 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: 04/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2014
• 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
• Patient Age: 58 YR