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

Model Number M001BP90520B0

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: the device was returned for analysis.Visual and microscopic examination of the 2cm pcb device identified that one of the 2cm blades and most of the pad was completely detached from the balloon material.Approximately 2mm of pad was left attached to the balloon material.This detached blade and pad section were not returned for analysis.All other blades were present and fully bonded to the balloon material.No issues were noted with the blades or pads that have contributed to the complaint incident.The returned device was attached to an encore inflation unit and positive pressure was applied to inflate the balloon.The balloon was successfully inflated to its rate of burst pressure of 10atm with no issues noted.Visual and microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and tactile examination found no kinks or damage along the shaft of the device.Visual and tactile examination identified no issues with the markerband or tip that could have contributed to the complaint incident.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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

Reportable based on additional information received on 21-may-2018.It was reported that the device was unable to cross the lesion.Vascular access was obtained utilizing the retrograde approach.The 99% stenosed target lesion was located in the forearm shunt.A 5.00mmx 2.0cmx 90cm 2cm peripheral cutting balloon¿ was selected for use.During procedure, the lesion was crossed using a non-bsc guidewire and then the balloon was advanced; however, it was unable to cross the lesion.The procedure was completed with a different device.No patient complications were reported and patient's status is stable.However, preliminary device analysis observed one of the blades and a section of the pad were detached and additional information indicated it was unknown when the blade detached.

• 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: 7597988
• MDR Text Key: 110960064
• Report Number: 2134265-2018-05385
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2018

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: 11/19/2019
• Device Model Number: M001BP90520B0
• Device Catalogue Number: BP905020B
• Device Lot Number: 21406940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2018
• Initial Date FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2017
• 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
• Treatment: GUIDEWIRE- FUGA; INTRODUCER SHEATH- 6F SHEATH