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

Model Number M001145520

Device Problems Difficult to Remove (1528); Material Rupture (1546); Device Damaged by Another Device (2915); Torn Material (3024)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that balloon rupture, circumferential tear, and removal difficulties occurred resulting in an unretrieved device fragment.The target lesion was located in the inferior vena cava (ivc).Following implantation of a stent in the ivc a 16-4/5.8/75 xxl¿ esophageal balloon catheter was advanced for post dilation.Upon inflation, the balloon was caught on the stent and ruptured.When the physician started to pull out the balloon, the balloon began to unravel circumferentially and come off the catheter.The device was advanced a little and pulled back again.The balloon continued to unravel and the physician cut off the tip of the balloon.Snaring was attempted but failed.Two more stents were implanted on both sides of the first stent to trap the stent and the balloon tip.No patient complications were reported.

Manufacturer Narrative

Bsc id: (b)(4).Tw: (b)(4).

Event Description

It was further reported that three wallstents were implanted without issue prior to the use of the 16-4/5.8/75 xxl¿ esophageal balloon catheter.

• 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: 6717503
• MDR Text Key: 80161828
• Report Number: 2134265-2017-07479
• 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: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2019
• Device Model Number: M001145520
• Device Catalogue Number: 14-552
• Device Lot Number: 0019692670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2016
• 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
• Patient Age: 55 YR