MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX? ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number M00516920

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that a wallflex partially covered esophageal stent was received by the customer on (b)(6) 2015.According to the complainant, upon inspection, the device packaging was damaged and the sterile seal was compromised.No visible damages were noted to the stent system.There was no patient or procedure involved.

Manufacturer Narrative

A wallflex partially covered esophageal stent was returned inside its packaging tray and inner pouch for analysis; however, the outer box was not returned.Visual examination of the returned device found that the manufacturing seal of the inner pouch was open; however, there was evidence of a seal along this end of the pouch.It was noted that the vendor seal was intact.No issues were noted with the profile of the device or the packaging tray.Device analysis determined that the condition of the returned device was consistent with the complaint incident as the manufacturing seal of the inner pouch was open.The noted defect likely occurred due to handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping.Therefore, the most probable root cause is handling damage.

Event Description

It was reported to boston scientific corporation on (b)(4) 2015 that a wallflex partially covered esophageal stent was received by the customer on (b)(6) 2015.According to the complainant, upon inspection, the device packaging was damaged and the sterile seal was compromised.No visible damages were noted to the stent system.There was no patient or procedure involved.

Manufacturer Narrative

Reported event of seal compromised.The device has been received for analysis; however, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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.

• Brand Name: WALLFLEX? ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4713971
• MDR Text Key: 6251791
• Report Number: 3005099803-2015-01064
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/12/2015
• Device Model Number: M00516920
• Device Lot Number: 0016376109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2013
• 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