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

Model Number M001145590

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Device evaluated by mfr.: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.(b)(4).

Event Description

It was reported that balloon rupture and separation occurred.The target lesion was located in the iliac vein.An 18-6/5.8/75 xxl¿ esophageal balloon catheter was advanced for pre-dilatation.The device was able to pre-dilate the lesion successfully and a stent was then placed.The same balloon catheter was used for post-dilatation.However, when the top 1/3 of the stent was being dilated at 12 atmospheres, the balloon ruptured and a piece of balloon material was left inside the patient.The patient went into surgery in order to remove the device fragment.The surgery was successful and the device fragment was completely removed.No further patient complications were reported and the patient's condition was stable.

• 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: 7647901
• MDR Text Key: 112657733
• Report Number: 2134265-2018-05768
• 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: 03/05/2021
• Device Model Number: M001145590
• Device Catalogue Number: 14-559
• Device Lot Number: 0021822782
• 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: 03/06/2018
• 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