MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

Model Number M001BP35620B0

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: 18 years or older (b)(4).Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the balloon observed that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The device was attached to an encore inflation unit and positive pressure was applied when liquid was observed to be leaking from a balloon pinhole approximately 5mm proximal to the proximal end of the distal markerband.An examination of the balloon material identified no issues which contributed to the initial issue.A visual and microscopic examination of the device identified no issues with the tip, markerbands or blades of the device that could have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and tactile examination identified no damage or any issues along the length of the shaft.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 operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 01-aug-2018.It was reported that the catheter failed to cross the lesion.The 80% stenosed target lesion was located in a moderately tortuous and moderately calcified left iliac artery.A 6.00mm / 2.0cm / 135cm otw 2cm peripheral cutting balloon¿ was selected for use.During procedure, after the device was inserted in a non bsc sheath, an attempt to advance the device to the target lesion was made.However, the lesion was hard and the device had difficult to advance.Somehow, dilatation was able to perform after the device reached the common iliac artery; however, the device failed to advance further to the external iliac artery.The device was removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and the patient's condition was good.However, device analysis revealed a balloon pinhole.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON¿
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• 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: 7790702
• MDR Text Key: 117432780
• Report Number: 2134265-2018-07355
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K070951
• 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: 08/01/2018

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: 04/16/2020
• Device Model Number: M001BP35620B0
• Device Catalogue Number: BP1356020B
• Device Lot Number: 0021999602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2018
• 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