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

Model Number M001145590

Device Problems Material Rupture (1546); Material Separation (1562); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a balloon rupture, tear and separation occurred and surgical removal was required the target lesion was located in the iliac vein.An unspecified stent was implanted.During stent post dilatation with the xxl¿ esophageal balloon, a balloon rupture occurred.While the balloon was being removed, the balloon apparently tore circumferentially and separated from the delivery shaft.An unsuccessful attempt was made to snare the balloon fragment inside of the patient's vein.Approximately two-thirds of the balloon was left in the patient.The patient was transferred to a nearby hospital for surgery where the balloon fragment was successfully removed.The patient is doing fine.

Manufacturer Narrative

Device evaluated by mfr: a visual examination of the balloon/device identified a complete circumferential tear in the balloon approximately 7mm distal to the proximal balloon bond.The damage observed is consistent with excessive tensile force being applied to the delivery system which may have occurred when the physician attempted to remove the device from the patient.The distal detached section of the balloon was not returned for analysis.One severe kink of the shaft was noted approximately 335mm proximal of the proximal balloon bond.This type of damage is consistent with excessive force being applied device.No other issues were identified during the product analysis.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.There was evidence that the device was used in a manner inconsistent with the labeled indications.The xxl device is an oesophageal balloon and the physician used this xxl device as part of a venous stenting procedure in the common iliac vein.The dfu states ''the xxl balloon dilatation catheter is intended for use in adult and adolescent populations to dilate strictures of the oesophagus.'' (b)(4).

Event Description

It was reported that a balloon rupture, tear and separation occurred and surgical removal was required the target lesion was located in the iliac vein.An unspecified stent was implanted.During stent post dilatation with the xxl esophageal balloon, a balloon rupture occurred.While the balloon was being removed, the balloon apparently tore circumferentially and separated from the delivery shaft.An unsuccessful attempt was made to snare the balloon fragment inside of the patient's vein.Approximately two-thirds of the balloon was left in the patient.The patient was transferred to a nearby hospital for surgery where the balloon fragment was successfully removed.The patient is doing 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: 7172886
• MDR Text Key: 96664999
• Report Number: 2134265-2017-13155
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2020
• Device Model Number: M001145590
• Device Catalogue Number: 14-559
• Device Lot Number: 0021295685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR