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

Model Number M001BPM4015140F0

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that catheter shaft detachment occurred.The target lesion was located in the superficial femoral artery (sfa).A 4.00mm x 1.5cm x 140cm small peripheral cutting balloon¿ was selected for use.During preparation, it was noticed that the blue balloon protection tool was difficult to remove.Furthermore, the protection tool was not removed and the shaft of the device was detached.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was received in two sections due to a break in the extrusion.An examination of the returned device found a break in the shaft polymer extrusion at the guidewire exit port.Further evaluation of the break site found that the extrusion was stretched at the site of the break.This type of damage is consistent with excessive force being applied to the delivery system during the removal of the balloon protector.The device was received with the balloon protector cap covering the balloon.The investigator was unable to apply negative pressure due to the break in the extrusion.However, the balloon protector was removed with some resistance encountered.The balloon was visually examined and no issues were noted.The internal dimension (id) of the balloon protector was measured at 0.0435 inches.This is with the specified range.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that catheter shaft detachment occurred.The target lesion was located in the superficial femoral artery (sfa).A 4.00 mm x 1.5 cm x 140 cm small peripheral cutting balloon¿ was selected for use.During preparation, it was noticed that the blue balloon protection tool was difficult to remove.Furthermore, the protection tool was not removed and the shaft of the device was detached.The procedure was completed with a different device.No patient complications were reported.

• 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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6182059
• MDR Text Key: 62691937
• Report Number: 2134265-2016-11751
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2016

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: 02/04/2019
• Device Model Number: M001BPM4015140F0
• Device Catalogue Number: BPM4015140F
• Device Lot Number: 18890024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• 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