MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX? COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565050

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2014

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-02791 and 3005099803-2014-03158 for the other associated device information.It was reported to boston scientific corporation that two wallflex enteral colonic stents were used in the colon during a stent placement procedure performed on (b)(6) 2014.The stent was being used to treat a 15 cm neoplastic stenosis in the sigma colon.Reportedly, the patient had a normal colorectal anatomy.According to the complainant, during the procedure, when the physician attempted to deploy the first stent (the subject of mfr report #3005099803-2014-02791) the blue outer sheath detached near the clear outer sheath on the distal portion of the delivery system.The stent failed to deploy and was removed from the patient.When the physician attempted to deploy the second stent (the subject of mfr report #3005099803-2014-03158), the blue outer sheath detached near the handle and the stent failed to deploy.The procedure was not completed due to this event.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 results which revealed the stent was received partially deployed.

Manufacturer Narrative

(b)(4) stent partially deployed.A visual examination of the returned device found that the stent was received partially deployed by 1mm.During the product analysis the investigator was unable to manually deploy the stent.The investigator was unable to advance and retract the outer sheath by hand.The clear outer sheath was slightly kinked at several positions along its length.The distal handle had detached from the dark blue outer sheath.It was also noted that the stainless steel tube was broken 10mm distal to proximal handle and severely kinked 3mm distal to the distal handle.The shaft was dissected at the proximal end of the clear outer sheath.The investigator noted that it was not possible to advance and retract the inner sheath.The proximal end of the inner sheath was withdrawn from the outer sheath and no issues were noted with its profile.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.Based on the condition of the returned device and the evaluation conducted, a definitive root cause for the reported failure could not be determined; therefore, the root cause classification is undeterminable.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? COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 4135331
• MDR Text Key: 4950382
• Report Number: 3005099803-2014-03158
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K061877
• 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
• Report Date: 09/11/2014

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: 03/26/2016
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 16849416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2014
• 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: 62 YR