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

Model Number M00565030

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was used during a duodenal stenting procedure performed on (b)(6) 2014.According to the complainant, the stent was being used to treat a malignant stricture.Reportedly, the patient's anatomy was not tortuous.During the procedure, after reaching the target lesion, the physician attempted to deploy the stent however, the handle broke halfway through the deployment.The partially deployed stent was removed from the patient.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 good.

Manufacturer Narrative

(b)(4) stent partially deployed.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.

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was used during a duodenal stenting procedure performed on (b)(6) 2014.According to the complainant, the stent was being used to treat a malignant stricture.Reportedly, the patient's anatomy was not tortuous.During the procedure, after reaching the target lesion, the physician attempted to deploy the stent however, the handle broke halfway through the deployment.The partially deployed stent was removed from the patient.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 good.

Manufacturer Narrative

Investigation results: visual examination of the returned device noted that the stent was received fully mounted on the delivery catheter.Device analysis confirmed that the outer sheath had detached from the distal handle and the investigator was unable to deploy the stent by manually retracting the outer sheath by hand.The dark blue outer sheath was creased and kinks were found at various positions along its length.These type of damages are consistent with excessive force exerted on the catheter during deployment.The stainless steel tube was broken exposing the inner.The break was 95mm distal to the proximal handle and it was also noted that the stainless steel tube was severely kinked at two separate positions along its length.The blue section of the outer sheath was dissected longitudinally and it was noted that some of the polytetrafluoroethylene (ptfe) coating had partially peeled away from the inside of the outer sheath.The stent and the inner were visually and microscopically examined and no issues were noted with their profiles that could have contributed to the complaint incident.The investigation concluded that this complaint is associated with a product that meets design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.Therefore, the most probable root cause classification for the reported failure is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• 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: 4228039
• MDR Text Key: 4971660
• Report Number: 3005099803-2014-03558
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2014

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 Expiration Date: 01/17/2016
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0016667739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2014
• Initial Date FDA Received: 11/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2014
• 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 Age: 82 YR