MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY XXL¿ VASCULAR; DILATOR, ESOPHAGEAL

Model Number M001145320

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon material had torn circumferentially from the proximal balloon bond.The torn balloon material was approximately 80mm in length was noted to be severely bunched up and pushed forward distally towards the tip of the device.A smaller section of balloon material was completely detached from the balloon material and was approximately 27mm in length.During analysis the investigator retracted the bunched-up balloon material.A visual and microscopic examination was performed on both sections of balloon material and no issues were noted with the balloon material that could have contributed to the complaint incident.A visual and tactile examination of the returned device identified severe kinking and shaft damage along the length of the device.Most of the damage was noted distal to the proximal balloon bond at the site of the balloon material detachment.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the shaft or proximal balloon bond that could have contributed to the complaint incident.A visual and microscopic examination of the tips and markerbands identified no damage or any issues 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 device analysis completed on 19apr2018.An unspecified incident occurred with the xxl¿ vascular balloon.No patient complications reported.However, returned device analysis revealed that the balloon was torn circumferentially and was fragmented.

• Brand Name: XXL¿ VASCULAR
• Type of Device: DILATOR, ESOPHAGEAL
• 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: 7519251
• MDR Text Key: 108439687
• Report Number: 2134265-2018-03986
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K952656
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2020
• Device Model Number: M001145320
• Device Catalogue Number: 14-532
• Device Lot Number: 0020314436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2017
• 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