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

Model Number M001BPM3015140F0

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the shaft was torn.A 3.00 mm/1.5 cm/140 cm small peripheral cutting balloon¿ was selected for use.During preparation, the blue cap was hard to remove and the shaft of the balloon got torn.The procedure was completed with another of the same device.No patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Device analysis determined that the condition of the returned device was consistent with the complaint incident.A complete break was identified in the shaft of the device.Multiple kinks were also noted along the shaft and hypotube of the device.The device was received in two separate pieces.One section consisted of hypotube and hub/manifold.The other section consisted of the shaft, balloon, blades, tip and markerbands.A visual and tactile examination of the shaft of the device identified a complete break in the midshaft extrusion 346mm proximal to the tip of the device.Multiple kinks were also noted along the length of the shaft polymer extrusion.This type of damage is consistent with excessive force being applied to the delivery.No issues were noted with the shaft that could have contributed to the complaint incident.A visual and tactile examination of the hypotube identified multiple kinks along the length of the hypotube.This type of damage is consistent with excessive force being applied to the delivery.No issues were noted with the hypotube that could have contributed to the complaint incident.A visual and microscopic investigation noted no damage to the balloon, tip or markerbands of the device that could have contributed to the complaint incident.A visual and microscopic investigation noted no damage to any of the blades.All blades were present and full bonded to the balloon material.No issues were noted that could have contributed to the complaint incident.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 shaft was torn.A 3.00mm/1.5cm/140cm small peripheral cutting balloon¿ was selected for use.During preparation, the blue cap was hard to remove and the shaft of the balloon got torn.The procedure was completed with another of the same device.No patient complications 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: 6815008
• MDR Text Key: 83630684
• Report Number: 2134265-2017-08430
• 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: 08/07/2017

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: 04/02/2017
• Device Model Number: M001BPM3015140F0
• Device Catalogue Number: BPM3015140F
• Device Lot Number: 0020480266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 09/13/2017
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2017
• 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