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

Model Number M001BPM4015140F0

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem No Patient Involvement (2645)

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by manufacturer: the device was returned for analysis.The balloon protector cap was also returned for analysis in position over the balloon.A shaft break was identified in the shaft polymer extrusion; multiple kinks were also noted along the length of the device.The device was received in two separate pieces for analysis.One section consisting of hypotube and the hub/manifold.The other section of shaft, balloon, blades, tip and markerbands.A visual and tactile examination of the shaft of the device identified a break in the shaft at the site of the guidewire exit port.This type of damage is consistent with excessive force being applied to the delivery system which may have occurred when difficulty was encountered removing the blue balloon protective sheath no issues were noted with the shaft polymer extrusion that could have contributed to the complaint incident.A visual and tactile examination identified multiple kinks along the length of the hypotube.The investigator also noted 60mm of the inner core still attached to the hypotube.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the hypotube that could have contributed to the complaint incident.The balloon protector was received in position over the balloon.Due to the condition of the returned device it was not possible to apply a vacuum; however the investigator removed the balloon protector cap and slight resistance was encountered.The lack of vacuum may have resulted in the resistance encountered.The returned balloon protector inner dimension was verified at 0.0435 inch using a pin gauge 'balloon protector 3.5mm thru 4mm'.This is within the specified range of 0.0420 inches to 0.0435 inches.No issues were identified that could have contributed to the complaint incident.A visual and microscopic investigation noted that the balloon was folded and had not been subjected to positive pressure.No issues or any damage was noted to the balloon, blades, tip or markerbands of the device that could have contributed to the complaint incident.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2017.It was reported that the balloon wrapping tool could not be removed.The 90% stenosed target lesion was moderately tortuous and moderately calcified artery.A 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ was selected for use.During preparation, a slight resistance was noted when the device was taken out from the hoop.The blue wrapping tool of the balloon was tight and could not be removed.The physician tried to remove it forcibly but it could not be removed.After several attempts of removing it, the shaft was damaged.The procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that the shaft was broken.

• 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: 7068885
• MDR Text Key: 93821525
• Report Number: 2134265-2017-11678
• 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
• Report Date: 11/10/2017

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: 11/04/2019
• Device Model Number: M001BPM4015140F0
• Device Catalogue Number: BPM4015140F
• Device Lot Number: 19925858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2016
• 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