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

Model Number M001145140

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.An examination of the outer pouch identified a 7.5cm wide tear at its distal end.As part of the device analysis, the outer pouch was opened and the when the inner pouch was removed, a tear was present at its distal end measuring 6cm in width.The tears on the outer pouches are located in the same location and are consistent with the packaging coming in contact with a sharp object.The device inside its tray did not appear to have been used and was not damaged.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

Reportable based on analysis completed on (b)(6) 2016.It was reported that packaging damage occurred.A 14-4/5.8/75 xxl¿ vascular balloon catheter was selected for use.However, during unpacking when the device was opened out of the box, it was noted that part of the packaging was open.No patient complications were reported.However, returned device analysis revealed inner pouch tear.

• Brand Name: XXL¿ VASCULAR
• 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: 5441896
• MDR Text Key: 38367260
• Report Number: 2134265-2016-00552
• 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: Other
• Type of Report: Initial
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2018
• Device Model Number: M001145140
• Device Catalogue Number: 14-514
• Device Lot Number: 0018137633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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