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

Model Number M001BP50520B0

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a blade detachment occurred.A 5.00mm x 2.0cm x 50cm otw peripheral cutting balloon¿ was selected for treatment of a mildly curved target lesion.The balloon catheter was inflated several times at nominal pressure; however, upon withdrawal, it was observed through cineangiocardiogram that the blade was dislodged inside a non bsc sheath.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual and microscopic examination was performed on the balloon material.The balloon was returned partially inflated with inflation medium.No issues or damage was noted on the balloon material.During analysis the investigator deflated and inflated the balloon material with no issues notes.A visual and microscopic examination of the 2cm pcb device identified that the entirety of one of the 2cm blades and most the pad was completely detached from the balloon material.The detached blade and pad were returned within the customer torn 6fr introducer sheath.The customer¿s sheath was noted to be torn approximately 25mm from the distal end.The detached blade and pad was noted to be imbedded within this tear in the sheath.All other blades were present and fully bonded to the balloon material.The sheath used during the procedure was damaged and could not be used during the analysis.The recommended sheath size for this 2cm pcb 5.00mm x 2.0cm x 50cm device is a 6fr introducer sheath.On analysis, the investigator applied a vacuum and successfully advanced the device through a 6fr boston scientific introducer sheath without any resistance or issues noted.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

It was reported that a blade detachment occurred.A 5.00mm x 2.0cm x 50cm otw peripheral cutting balloon was selected for treatment of a mildly curved target lesion.The balloon catheter was inflated several times at nominal pressure; however, upon withdrawal, it was observed through cineangiocardiogram that the blade was dislodged inside a non bsc sheath.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 7523609
• MDR Text Key: 108634510
• Report Number: 2134265-2018-04281
• 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,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2019
• Device Model Number: M001BP50520B0
• Device Catalogue Number: BP505020B
• Device Lot Number: 0021486807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2017
• 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