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

Model Number M001145530

Device Problems Difficult to Remove (1528); Material Rupture (1546); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2014

Event Type  Injury  

Event Description

Same case a mdr id # 2134265-2014-00816.It was reported that balloon rupture, balloon tear and removal difficulties occurred.The target lesion was located in the iliac venous bifurcation.The 24x35/11fr wallstent endoprosthesis stent was advanced and deployed to the lesion but the proximal end failed to open up fully.A 6-4/5.8/120 xxl esophageal balloon catheter was advanced to post dilate the proximal end of the stent however the balloon ruptured circumferentially at 8 atmospheres on the second inflation.It was also noted that the balloon was torn.It was unknown if there were any detached balloon fragments.An attempt to remove the balloon was done however it got stuck on the 24x35/11fr wallstent endoprosthesis stent strut.The physician tried to remove the balloon catheter out by pushing and pulling but was unsuccessful and then the stent "shoot up" and migrated into the distal vena cava.An unspecified sheath was advanced followed by another unspecified long sheath over the balloon catheter to remove it but failed.Instead, a surgical cutdown was performed and the balloon was removed.An unspecified filter was placed in the distal vena vaca to prevent the stent from migrating further.Another 22cm wallstent endoprosthesis stent was deployed and the procedure was completed.No further patient complications were reported and the patient's status was fine.

Manufacturer Narrative

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 medwatch will be filed.(b)(4).

• Brand Name: XXL? ESOPHAGEAL
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3626865
• MDR Text Key: 4207888
• Report Number: 2134265-2014-00817
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2015
• Device Model Number: M001145530
• Device Catalogue Number: 14-553
• Device Lot Number: 15466410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR