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

Model Number M001145540

Device Problems Detachment Of Device Component (1104); Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user.The xxl balloon was used in the femoral vein.However, the direction for use states ¿the xxl balloon dilatation catheter is intended for use in adult and adolescent populations to dilate strictures of the esophagus".(b)(4).

Event Description

It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in the femoral vein.A 16-6/5.8/75cm xxl¿ esophageal balloon catheter was advanced for dilatation.The balloon was inflated with 20cc syringe and manual pressure was applied.However, during the third inflation, the balloon ruptured.The balloon was withdrawn back into the access sheath.The resistance of the balloon material being withdrawn through the sheath without negative pressure caused the distal portion of the balloon material to bunch and when force was applied, the distal portion of the balloon and the radiopaque tip became separated from the shaft.The physician pinned the detached portion of the device in the external iliac vein using a wallstent.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.

• Brand Name: XXL¿ ESOPHAGEAL
• 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: 7647577
• MDR Text Key: 112659827
• Report Number: 2134265-2018-05769
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952656
• 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
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2021
• Device Model Number: M001145540
• Device Catalogue Number: 14-554
• Device Lot Number: 0022015572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2018
• 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
• Patient Outcome(s): Required Intervention