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

Model Number M001145570

Device Problems Break (1069); Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2014

Event Type  Injury  

Event Description

It was reported that removal difficulty, shaft break and balloon tear occurred.The stenosed target lesion was located in the iliac vein.An unspecified 11fr sheath was placed.A non bsc inflation device was used and a visipaque 320 contrast media was utilized with a contrast ratio of 30/70.A 18-4/5.8/75 xxl¿ esophageal balloon catheter was advanced to the lesion to treat the waist.Then a 20x4mm wallstent was advanced and deployed to the target lesion.Post dilation was performed for approximately 30 to 60 seconds at 4 to 5 atmospheres using the same 18-4/5.8/75 xxl¿ esophageal balloon catheter.Upon deflation of the balloon, blood was noted in the inflation device.The balloon was deflated completely under fluoroscopy however it would not retract from the sheath despite multiple attempts.Attempts were done to retract the balloon catheter without the sheath in place but was unsuccessful.Considerable force was used to remove the device until the balloon catheter broke and the balloon was torn.The detached fragments remained in the patient's common femoral vein.The procedure was not completed due to this event.The detached portion were successfully removed from the patient through surgery with no residue.No further patient complications we reported and the patient recovered well.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluated by mfr: a visual examination of the returned device found a break had occurred in the shaft at 7.8cm distal to the strain relief.A complete balloon circumferential tear had occurred in the balloon at approximately 2.8cm distal to the proximal touch up at the proximal bond.A break was also evident in the shaft inside the balloon area at 2.8cm distal to the proximal touch up at the proximal bond.The main body of the balloon was bunched.When the balloon was unraveled it was identified that the distal end of the balloon was fully bonded on at the distal bond site and the tip was evident.However, a section of the broken shaft, from the break site distal to the proximal touch up and the actual tip section of the device, was missing.A closer examination of the balloon found no other tears.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the device was being used to post dilate a wallstent in the iliac vein and 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 reported that removal difficulty, shaft break and balloon tear occurred.The stenosed target lesion was located in the iliac vein.An unspecified 11fr sheath was placed.A non bsc inflation device was used and a visipaque 320 contrast media was utilized with a contrast ratio of 30/70.A 18-4/5.8/75 xxl¿ esophageal balloon catheter was advanced to the lesion to treat the waist.Then a 20x4mm wallstent was advanced and deployed to the target lesion.Post dilation was performed for approximately 30 to 60 seconds at 4 to 5 atmospheres using the same 18-4/5.8/75 xxl¿ esophageal balloon catheter.Upon deflation of the balloon, blood was noted in the inflation device.The balloon was deflated completely under fluoroscopy; however, it would not retract from the sheath despite multiple attempts.Attempts were done to retract the balloon catheter without the sheath in place but was unsuccessful.Considerable force was used to remove the device until the balloon catheter broke and the balloon was torn.The detached fragments remained in the patient's common femoral vein.The procedure was not completed due to this event.The detached portion were successfully removed from the patient through surgery with no residue.No further patient complications we reported and the patient recovered well.

• 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: 3882113
• MDR Text Key: 4544190
• Report Number: 2134265-2014-03461
• 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,Followup
• Report Date: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2017
• Device Model Number: M001145570
• Device Catalogue Number: 14-557
• Device Lot Number: 0016790972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• 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