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

Model Number M001PCB60201350

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that blade detachment occurred.A 6.00mm x 2.0cm x 135cm 2cm peripheral cutting balloon® was selected for upper extremity fistulagram.Upon withdrawing the cutting balloon catheter from the patient's body, it was noticed that the blade came off.Procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual and microscopic examination was performed on the blade/pad of the returned device.It was noted that a section of one of the blades and pads, approximately 13mm in length was partially detached from the proximal end of the balloon material.The remaining section of blade and pad measuring 7mm in length was undamaged and fully bonded to the balloon material.The entire 2cm of blade was accounted for.The damage identified can potentially be a result of the resistance encountered during the advancement or withdrawal of the device.All other blades were intact and fully bonded to the balloon material.No issues were noted with the blades or pads that could have contributed to the complaint incident.A visual and microscopic examination of the balloon noted that the balloon was unfolded and inflation medium was observed within the balloon material which indicates it had been subjected to positive pressure.No damage or any issues were noted with the balloon material that could have contributed to the complaint incident.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination on the device identified multiple kinks along the length of the device.This type of damage is consistent with excessive force being applied to the delivery system.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 blade detachment occurred.A 6.00mm x 2.0cm x 135cm 2cm peripheral cutting balloon was selected for upper extremity fistulagram.Upon withdrawing the cutting balloon catheter from the patient's body, it was noticed that the blade came off.Procedure was completed with a different 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: 7297597
• MDR Text Key: 101151709
• Report Number: 2134265-2018-01327
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001PCB60201350
• Device Catalogue Number: PCB6020135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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