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 05/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a shaft break occurred.The chronic total occlusion (cto) target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).A 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ was selected for use.During unpacking while removing the balloon protector, the shaft broke near the base.Furthermore, it was noted that the shaft was cracked.The device was not used and the procedure was completed with another of the same device.No patient complications were reported and the patient¿s status is good.

Manufacturer Narrative

Device evaluated by mfr: device was returned for analysis.The balloon protector was positioned over the balloon.The balloon was tightly folded.The balloon and tip sections of the device were visually and microscopically examined and no issues were noted.The device was received in two sections due to a break in the midshaft at the port site.There was evidence of material resistance and stretching at the break site.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 break occurred.The chronic total occlusion (cto) target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).A 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ was selected for use.During unpacking while removing the balloon protector, the shaft broke near the base.Furthermore, it was noted that the shaft was cracked.The device was not used and the procedure was completed with another of the same device.No patient complications were reported and the patient¿s status is 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: 5704539
• MDR Text Key: 46762190
• Report Number: 2134265-2016-04780
• 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: 05/09/2016

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: 12/07/2018
• Device Model Number: M001BPM4015140F0
• Device Catalogue Number: BPM4015140F
• Device Lot Number: 18710183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 06/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2015
• 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