MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ? DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565010

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be used in the duodenum during a procedure performed on (b)(6) 2014.According to the complainant, during preparation, the physician removed the stent out of the box and it was noted that the inner sterile pouch was compromised.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date (b)(4) seal compromised.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: WALLFLEX ? DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• 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: 4210343
• MDR Text Key: 4985433
• Report Number: 3005099803-2014-03506
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062750
• 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
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2014
• Initial Date FDA Received: 10/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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