MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SMALL PERIPHERAL CUTTING BALLOON¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number M001BPM4015140F0

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2015

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that catheter removal difficulties occurred.Vascular was obtained via the left femoral artery.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left superficial femoral artery (sfa).After a non-bsc guide wire crossed the lesion, a 4.00mm/1.5cm/140cm small peripheral cutting balloon was delivered via the guide wire and then dilation was performed.The balloon was completely deflated after 60 seconds.After, removal of the whole delivery system was attempted but resistance was encountered.Slight force was applied to pull the device and it was removed from the patient without trouble.However when the device was checked, it was noted that the shaft was stretched.The procedure was completed with another small peripheral cutting balloon⮠no patient complications were reported and the patient's condition was good.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.No damage was noted to the tip, balloon or blades of the device.A visual examination of the returned device identified that the hypotube was kinked at various locations along its length.The midshaft was severely stretched down and kinked.The inner and outer extrusions were severely stretched just distal to the wire lumen port.This stretching extended distally along the shaft for a total length of 1cm.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 catheter removal difficulties occurred.Vascular was obtained via the left femoral artery.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left superficial femoral artery (sfa).After a non-bsc guide wire crossed the lesion, a 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ was delivered via the guide wire and then dilation was performed.The balloon was completely deflated after 60 seconds.After, removal of the whole delivery system was attempted but resistance was encountered.Slight force was applied to pull the device and it was removed from the patient without trouble.However when the device was checked, it was noted that the shaft was stretched.The procedure was completed with another small peripheral cutting balloon¿.No patient complications were reported and the patient's condition was good.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5299442
• MDR Text Key: 33586901
• Report Number: 2134265-2015-08918
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020
• 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,Followup
• Report Date: 11/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2018
• Device Model Number: M001BPM4015140F0
• Device Catalogue Number: BPM4015140F
• Device Lot Number: 0018491003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2015
• Initial Date FDA Received: 12/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2015
• 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