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

Model Number M001BPM4015140F0

Device Problems Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

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 catheter shaft detachment occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac artery (cia).A 4.00mm/1.5cm/140cm small peripheral cutting balloon¿ was selected for use.During preparation when the physician attempted to remove the balloon cover, it was noted that the shaft was detached.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Updated: device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes device evaluated by mfr: the device was returned for evaluation.A visual examination found no damage to the tip, balloon, or blades.The internal dimension (id) of the balloon protector was measured at 0.0435 inches using pin gauge set.This is within the specified range of 0.0420 inches to 0.0435 inches.A visual and tactile examination of the hypotube shaft found multiple kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the polymer shaft extrusion found that the polymer shaft had detached at the gas port.This type of damage is consistent with excessive force being applied to the delivery system.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 catheter shaft detachment occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified common iliac artery (cia).A 4.00 mm/1.5 cm/140 cm small peripheral cutting balloon¿ was selected for use.During preparation when the physician attempted to remove the balloon cover, it was noted that the shaft was detached.The procedure was completed with another of the same device.No patient complications were 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: 6243464
• MDR Text Key: 64602918
• Report Number: 2134265-2016-12265
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: M001BPM4015140F0
• Device Catalogue Number: BPM4015140F
• Device Lot Number: 18862922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• 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