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

Model Number M001BPM4015140F0

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the catheter was broken.The (b)(4)% stenosed target lesion was located at the moderately tortuous and moderately calcified superficial femoral artery(sfa).A 4.00mm/1.5cm/140cm small peripheral cutting balloon(tm) monorail was selected for use.During preparation, the physician pulled the device from the hoop and attempted to remove the blue cap from the tip.However, resistance was encountered upon pulling the blue cap harder.It was then noted that the middle part of the catheter was detached.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was returned for evaluation.A visual examination on the catheter observed a break in the midshaft at the port site.As a result of the break it was not possible to apply a vacuum to the balloon to remove all air.However, the balloon protector was removed from the balloon with no force required.The balloon protector cap was returned over the balloon.The proximal part of the balloon was exposed which is indicative of the balloon protector being pulled distally.The returned balloon protector inner dimension was within the specification.Upon removal of the protector cap, there was no damage noted to the tip, balloon, or blades.The shaft damage noted during analysis is consistent with excessive force being applied to the delivery system during an attempt at removal of the balloon protector from the balloon.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 the catheter was broken.The 90% stenosed target lesion was located at the moderately tortuous and moderately calcified superficial femoral artery(sfa).A 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ monorail was selected for use.During preparation, the physician pulled the device from the hoop and attempted to remove the blue cap from the tip.However, resistance was encountered upon pulling the blue cap harder.It was then noted that the middle part of the catheter was detached.The procedure was completed with another of the same device.No patient complications were reported and the patient's status 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: 5485444
• MDR Text Key: 39847146
• Report Number: 2134265-2016-01367
• 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: 02/10/2016

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: 11/08/2018
• Device Model Number: M001BPM4015140F0
• Device Catalogue Number: BPM4015140F
• Device Lot Number: 0018610632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 03/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2015
• 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