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

Model Number M001BP50620B0

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years or older.The device was returned together with a non bsc introducer sheath.A visual examination of the balloon noted that the balloon was unfolded and crinkled which indicates that the balloon had been inflated and the crinkling of the balloon material may have occurred during attempts to remove the device.Blood was also noted within the balloon material which is evidence of a device leak.The device was then attached to an encore inflation unit and vacuum was applied.The device was then removed from the torn introducer sheath; however, due to the condition of the balloon material, resistance was encountered during withdrawal of the balloon from the hub of the introducer sheath.The device was again attached to an encore inflation device filled with glycerol/h20 solution and positive pressure was applied; however, the balloon could not be inflated due to the presence of solidified blood within the inflation lumen and balloon.The device was soaked in a water bath and was removed from the bath and subsequently was reattached to an encore inflation device and positive pressure was applied; however, liquid was observed escaping from a pinhole leak in the balloon material approximately 9mm distal to the distal edge of the proximal markerband.No issues were noted with the balloon material.An examination of the device identified that one of the blades was slightly damaged on the device.A microscopic examination identified that 1mm of one of the blades was lifted from the balloon material.This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device.The remaining 19mm of the blade and the entire pad was intact and fully bonded to the balloon material.All other blades were intact and fully bonded to the balloon material.No other issues were noted with the blades or pads.No issues noted as well with the tip or markerbands.A visual and tactile examination of the device observed multiple kinks along the length of the device.No other issues were noted with the shaft.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

Reportable based on device analysis completed on 20-dec-2017.It was reported that the non bsc introducer sheath became detached upon removal of the balloon catheter.The 90% target lesion was located on a mildly tortuous and mildly calcified shunt vessel.A 6.00mm / 2.0cm / 50cm otw peripheral cutting balloon¿ was inserted through a non bsc introducer sheath for percutaneous transluminal angioplasty.The balloon was inflated 3 times at 6atms respectively for 30seconds; however, it was noted that the non bsc introducer sheath became detached upon removal of the balloon catheter.There were no patient complications reported.However, device analysis results revealed that about 1mm from one of the blades became lifted.

• 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: 7143938
• MDR Text Key: 95672885
• Report Number: 2134265-2017-13172
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2019
• Device Model Number: M001BP50620B0
• Device Catalogue Number: BP506020B
• Device Lot Number: 0020637614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2017
• 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
• Treatment: GUIDEWIRE: MEISTER; INTRODUCER SHEATH: MEDIKIT 6F