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

Model Number 24628

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(6).Device evaluated by manufacturer: the device was returned for analysis.The returned device was received together with customers introducer sheath.The customers sheath was torn along its entire length.As the customers sheath was torn the investigator choose a new 6fr introducer sheath for investigation purposes.On analysis, the investigator applied a vacuum and successfully advanced the device through a 6fr boston scientific introducer sheath and successfully withdrew the device without any resistance or issues noted.No issues were noted that could have contributed to the complaint incident.A visual and microscopic examination was performed on the returned device.It was noted that one of the blades approximately 20mm in length was completely detached from the balloon material.A section of blade pad approximately 9mm in length was also detached from the balloon material.The remaining section of pad, approximately 11mm in length remained fully bonded to the balloon material.The detached blade and pad section were not returned for analysis.The damage identified is consistent with resistance being encountered during the withdrawal of the device.All other blades were intact and fully bonded to the balloon material.The balloon was unfolded which indicates it had been subjected to positive pressure.No issues were identified with the balloon material that may have contributed to the complaint incident.No issue was observed with the tip or markerbands of the device.A visual and tactile examination identified a severe kink on the shaft of the returned device.This type of damage is consistent with excessive being applied as the user attempts to cross a lesion.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 03-jan-2019.It was reported that the blade was bent and the sheath was torn.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified shunt limb.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During withdrawal, after the balloon was slowly deflated, it was noted that the blades of the balloon became bent and the sheath became torn.The procedure was not completed due to this event.No patient complications were reported.However, device analysis revealed that one of the blades approximately 20mm in length was completely detached from the balloon material.

• Brand Name: 2CM PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8282075
• MDR Text Key: 134255800
• Report Number: 2134265-2019-00363
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/28/2019

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 Model Number: 24628
• Device Catalogue Number: 24628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/28/2019
• 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
• Treatment: GUIDEWIRE: KYOUSHA; INTRODUCER SHEATH: MOSQUITO 6F