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

Model Number M001145570

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a catheter shaft break occurred.The target lesion was located in the calcified left brachiocephalic vein.The physician tried to inflate a 7.00mm/2.0cm/135cm 2cm peripheral cutting balloon however, the balloon ruptured and immediately deflated.During the same procedure, an xxl esophageal balloon catheter was used but the shaft of the device broke in half.The physician then used a snare to retrieve the device and everything was removed.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Device analysis determined that the condition of the returned device was not consistent with the complaint.Analysis of the returned device found no issues that could be potentially related to the reported complaint incident.A visual and microscopic examination found no issues with the tip section of the device.A visual and microscopic examination found no issue with the profile of the markerbands.A longitudinal balloon tear was identified 50mm proximal to the tip.The tear measured approximately 2mm in length.There was no issue with the profile of the shaft.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that a catheter shaft break occurred.The target lesion was located in the calcified left brachiocephalic vein.The physician tried to inflate a 7.00mm/2.0cm/135cm 2cm peripheral cutting balloon however, the balloon ruptured and immediately deflated.During the same procedure, an xxl esophageal balloon catheter was used but the shaft of the device broke in half.The physician then used a snare to retrieve the device and everything was removed.No patient complications were reported.

• Brand Name: XXL¿ ESOPHAGEAL
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5348920
• MDR Text Key: 35203943
• Report Number: 2134265-2016-00069
• 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: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2018
• Device Model Number: M001145570
• Device Catalogue Number: 14-557
• Device Lot Number: 18228426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 01/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2015
• 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