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

Model Number M001BP90720B0

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The 2cm pcb had one of the blades and pad partially detached from the balloon.An examination of the device identified that 16mm of blade and 11mm of pad was partially detached on the proximal end of balloon.Leaving 4mm of blade and 9mm of pad still attached to the balloon.This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device most likely due to the operational context of the procedure.The total size of the blade is 2cm.All other blades were intact and fully bonded to the balloon surface.The balloon was not folded and saline solution was visible within the balloon which indicated it had been subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied to rated burst pressure of 10atm (atmospheres).No issues were observed with the balloon.No issues were observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination found no damage to the shaft of the device.The sheath used during the procedure was not returned for analysis.No other issues were identified during the product analysis.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).

Event Description

It was reported that the blade was lifted.The target lesion was located in the left upper arm.A 7.00mm/ 2.0cm/ 90cm otw 2cm peripheral cutting balloon¿ was selected for use.During procedure, the physician was able to use an unspecified 5mm cutting balloon with no issues.After usage and completely deflating the 7mm balloon, it was noticed that the device was difficult to get out of the sheath.The physician placed an empty 20ml syringe on the device; however, it was still difficult to remove the balloon.The physician had to have the nurse do the same while the physician removed the balloon.Finally when successfully removing the balloon, it was noted that one of the blades was almost 2/3's of the way out of the balloon.The procedure was completed with this device.No further patient complications were reported and the patient's status was okay.

• 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: 6600993
• MDR Text Key: 76416338
• Report Number: 2134265-2017-05247
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001BP90720B0
• Device Catalogue Number: BP907020B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2017
• 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