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

Model Number M001145550

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546); Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a balloon rupture, difficulty removing, a balloon tear, and balloon detachment occurred.The balloon fragment was unable to be retrieved.The target lesion was located in the common iliac vein.A 18-2/5.8/75 xxl¿ esophageal balloon catheter was advanced for post-dilation.The balloon ruptured and force was used in an attempt to remove the balloon through the sheath, when a circumferential tear as noted and the balloon detached from the shaft and was floating over the guidewire inside the patient.Snaring was attempted, however, unsuccessful.A wallstent was deployed to trap the balloon components against the vessel wall.The procedure was complete and the patient status was fine.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The distal section of the device consisting of shaft, balloon material, tip and marerkerbands was not returned for analysis.A visual examination identified a completed circumferential tear in the balloon approximately 14mm distal to the proximal balloon bond.The break in the shaft was identified 15mm distal to the balloon bond.No issues were noted with the shaft or balloon material that could have contributed to the complaint incident.One kink was noted 1mm distal to the strain relief.The damage observed is consistent with excessive force being applied to the delivery system which may have occurred when the physician attempted to remove the device after the balloon tore circumferentially.The distal detached section of the device was not returned for analysis.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 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 dfu 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 further reported that the physician was not using an inflation device, instead had the balloon attached to a large syringe and was inflating by hand and on initial inflation, the balloon ruptured.

• 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: 6970874
• MDR Text Key: 90024719
• Report Number: 2134265-2017-10381
• 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,Followup
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: M001145550
• Device Catalogue Number: 14-555
• Device Lot Number: 0020774780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR