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

Model Number M00565120

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was used in the ileocecum during a stent implantation 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, the physician advanced the device to the target area and attempted to release the stent, however, resistance was encountered.The handle broke and detached from the outer sheath.The partially deployed stent was removed from the patient with the scope.The procedure was not completed because the same device was unavailable.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

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.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

Investigation results: a visual examination of the returned device confirmed that the outer sheath had broken 1mm distal to the distal handle.Additionally the dark blue outer sheath was broken 245mm distal to the proximal end of the stainless steel shaft.The distal portion of the break was not received for analysis thus, it was not possible to attempt stent deployment.Device analysis determined that the condition of the returned device was consistent with the complaint incident.Based on the condition of the returned device, the noted issue was 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 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.

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was used in the ileocecum during a stent implantation 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, the physician advanced the device to the target area and attempted to release the stent, however, resistance was encountered.The handle broke and detached from the outer sheath.The partially deployed stent was removed from the patient with the scope.The procedure was not completed because the same device was unavailable.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.

• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4051873
• MDR Text Key: 4732892
• Report Number: 3005099803-2014-02937
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• 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,Followup
• Report Date: 08/11/2014

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: 04/01/2016
• Device Model Number: M00565120
• Device Catalogue Number: 6512
• Device Lot Number: 16863342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2014
• Initial Date FDA Received: 09/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2014
• 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