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

Model Number M001BPM3515140F0

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a shaft detachment occurred.The 90% stenosed target lesion was locate in the mildly tortuous and mildly calcified left femoral artery.A 3.50 mm/4.5 cm/140 cm small peripheral cutting balloon was selected for use.During preparation, it was noted that the balloon protector was difficult to remove from the balloon.Subsequently, the shaft part became detached.The procedure was completed with another of the device.No patient complications were reported and the patient's condition was good.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual examination of the balloon, blades, tip was performed and revealed no damage.The balloon protector was still attached to the balloon.Internal dimension of the balloon protector was taken and met specified range.A visual and tactile examination of the hypotube shaft was taken and revealed that no kinks were found along the shaft.Also, a visual and tactile examination of the polymer shaft extrusion found that the mid-shaft showed signs of stretching and had detached 4mm proximal from extruded polymer shaft.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 a shaft detachment occurred.The 90% stenosed target lesion was locate in the mildly tortuous and mildly calcified left femoral artery.A 3.50mm/ 4.5cm/140cm small peripheral cutting balloon¿ was selected for use.During preparation, it was noted that the balloon protector was difficult to remove from the balloon.Subsequently, the shaft part became detached.The procedure was completed with another of the device.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: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6243475
• MDR Text Key: 64602345
• Report Number: 2134265-2016-12320
• 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: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2018
• Device Model Number: M001BPM3515140F0
• Device Catalogue Number: BPM3515140F
• Device Lot Number: 0018747505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2016
• 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