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

Model Number 24630

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination was identified no issues or damage to the blades of the returned device.All blades were undamaged and fully bonded to the balloon material.An examination of the returned device identified that the balloon had been inflated.Blood was noted inside the device which is evidence of a device leak.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of a shaft leak.A microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint.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 identified a severe kinking at more than one location on the shaft of the device.This type of damage is consistent with excessive force being applied to the device.During analysis the returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon and liquid was observed exiting from the site of one of the severe shaft kinks located at the proximal balloon bond.No other issues were noted with the shaft of the device.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 17dec2020.It was reported that there was a device performance issue with the 7.00mm / 2.0cm / 90cm peripheral cutting balloon.The procedure was successfully completed with another peripheral cutting balloon.There were no patient complications reported and the patient was fine.However, device analysis found a shaft leak.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11151381
• MDR Text Key: 226265198
• Report Number: 2134265-2020-18885
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2022
• Device Model Number: 24630
• Device Catalogue Number: 24630
• Device Lot Number: 0025725273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1