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

Model Number M00565060

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was used in the sigmoid colon during a flexible sigmoidoscopy with stent placement procedure performed on (b)(4) 2014.Reportedly, the patient had a difficult airway.According to the complainant, during the procedure, the physician attempted to deploy the stent and the handle detached from the outer sheath.The stent and the scope were removed together from the patient.The physician tested the stent outside the patient and was able to release it ¼ of the way.The stent was reconstrained and the stent and scope were reinserted to the patient.The physician made another attempt to deploy the stent but only ¼ of the stent could be released.The physician removed the partially deployed stent from the patient.The procedure was completed with a wallstent 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 ¿awake and doing exceptionally well.¿.

Manufacturer Narrative

Reported event of 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.

Manufacturer Narrative

Visual examination of the returned device noted that the distal handle had detached from the blue outer sheath.Due to the returned device's condition, it was not possible to deploy the stent of the device.The outer diameter of the sheath distal to the break was measured and was within specification.The markerband position and the stent holder were visually examined and no issues were noted with their profiles.The returned stent was partially deployed by 42mm.The dark blue outer sheath was severely kinked at numerous positions along its length and accordioned.During the product analysis, the investigator was able to reconstrain the stent by hand.The investigator observed that the stainless steel shaft was severely kinked.This type of damage is consistent with excessive force being applied to the delivery system.The outer diameter of the exterior tube was measured at several positions and was within specification.The stent holder was visually examined and no issues were noted with its profile that could have contributed to the complaint incident.The shaft was dissected at the proximal end of the clear outer sheath.The distal end of the inner lumen and stent were withdrawn from the outer sheath and no issues were noted with their profiles.The proximal end of the inner 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 delaminated.Based on the event description and the condition of the returned device, it is likely the noted damages were due to procedural factors such as 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 search of the complaint database revealed that no similar complaints exist for the specified lot.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was used in the sigmoid colon during a flexible sigmoidoscopy with stent placement procedure performed on (b)(6) 2014.Reportedly, the patient had a difficult airway.According to the complainant, during the procedure, the physician attempted to deploy the stent and the handle detached from the outer sheath.The stent and the scope were removed together from the patient.The physician tested the stent outside the patient and was able to release it ¼ of the way.The stent was reconstrained and the stent and scope were reinserted to the patient.The physician made another attempt to deploy the stent but only ¼ of the stent could be released.The physician removed the partially deployed stent from the patient.The procedure was completed with a wallstent 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 ¿awake and doing exceptionally well.¿.

• 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3869342
• MDR Text Key: 4456649
• Report Number: 3005099803-2014-02266
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 05/22/2014

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: Nurse
• Device Expiration Date: 03/11/2016
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 0016809291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2014
• Initial Date FDA Received: 06/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2014
• 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