MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565030

Device Problems Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter's address: (b)(6).(b)(4).A wallflex duodenal stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was received partially deployed.The outer sheath was kinked at 3 inches from the exterior tube handle (proximal end).The clear outer sheath and the inner member at the distal end were also kinked.Functional evaluation revealed the stent could not be deployed using the delivery system as received; however, the stent was deployed manually by gripping the outer sheath and pulling the tip distally.The stent was found kinked.No other issues with the stent and delivery system were noted.The damages noted of the returned device are consistent with excessive force being applied during the attempt deployment outside the patient.Taking all available information into consideration, the investigation concluded that the interaction between the user and the device caused or contributed to the event.Therefore, the most probable root cause is unintended use error caused or contributed to event.A labeling review was performed, and from the information available, this device was used per the directions for use (dfu)/ product label.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that a wallflex duodenal stent was to be used to treat a malignant stenosis in the colon during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure, the physician tried to deploy the stent outside the patient.Reportedly, the stent was able to be deployed partially, however, the stent could no longer be reconstrained.The procedure was completed with another wallflex duodenal stent.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 stable.Note: this event has been deemed an mdr reportable event based on investigation result which revealed the stent was kinked.

• Brand Name: WALLFLEX DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9598405
• MDR Text Key: 189910323
• Report Number: 3005099803-2019-06525
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2020

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: 10/05/2020
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0022756616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2018
• 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: 78 YR
• Patient Weight: 62