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 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.   (b)(4).  device evaluated by mfr: the complaint device was not received for 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.The directions 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

Same as mdr id: 2134265-2018-00168.It was reported that balloon rupture and balloon detachment occurred.The target lesion was located in a vessel in the pelvic area.A 18-6/5.8/75mm xxl¿ esophageal balloon catheter was advanced for dilatation.However, during the third inflation at 5 atmospheres for 30 seconds, the balloon ruptured.The device was completely removed from the patient.Another 18-6/5.8/75mm xxl¿ esophageal balloon catheter was advanced to perform dilatation.However, during the second inflation at 5 atmospheres for 30 seconds, the balloon ruptured.While removing the device from the sheath, it was noted that the balloon was detached from the catheter.The detached balloon was then removed together with the sheath.The procedure was completed with another of the same 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: 7222221
• MDR Text Key: 98522793
• Report Number: 2134265-2018-00169
• 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: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M001145590
• Device Catalogue Number: 14-559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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