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

Model Number M00565080

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was used in the colon during a stenting procedure performed on (b)(6)2014.According to the complainant, the stent was being placed to treat a 4 cm malignant stricture.Reportedly, the patient¿s anatomy was not tortuous and the was not dilated prior to stent placement.During the procedure, the physician was not able to deploy the stent.It was noted that the handle detached from the outer sheath.The physician removed the stent and delivery system from the patient.The procedure was completed with another 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 in a "normal manner." note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the stent was partially deployed by 20mm.

Manufacturer Narrative

Evaluation finding of stent partially deployed.A visual examination of the returned device found that the stent was partially deployed by 20mm.The outer sheath was detached from the distal handle and the stainless steel shaft was bent.It was also noted that the outer sheath was stretched for 140mm at its proximal end and was also accordioned at several locations along this area.The distal end of the shaft where the stent was mounted was kinked.During analysis it was possible to retract the outer sheath to; however, a restriction was then met.The shaft was dissected at the proximal end of the clear outer sheath.It was not possible to retract the outer sheath but it was possible to move the outer sheath distally off the stainless steel shaft.The stent and distal end of the inner lumen were withdrawn from the outer sheath and no issues were noted with their profiles.The proximal end of the outer sheath was dissected longitudinally and it was noted that polytetrafluoroethylene (ptfe) coating had partially peeled away from inside of the outer sheath.The noted damages indicate difficulty was experienced during deployment and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.A review of the device labeling and directions for use (dfu) was performed and no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.

• Brand Name: WALLFLEX? COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3688843
• MDR Text Key: 4253854
• Report Number: 3005099803-2014-01366
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K061877
• 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: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2015
• Device Model Number: M00565080
• Device Catalogue Number: 6508
• Device Lot Number: 0016027749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• 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