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

Model Number M00565110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 07/07/2014

Event Type  Injury  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report #3005099803-2014-02597 and 3005099803-2014-02648 for the other associated device information.It was reported to boston scientific corporation that a wallflex enteral colonic stent and a hydra jagwire guidewire were used in the sigmoid colon during a colonic stenting procedure performed on (b)(6) 2014.According to the complainant, the stent was being implanted as a bridge to surgery to treat a 5cm stricture due to a malignancy.According to the physician, the patient has never undergone chemotherapy nor radiotherapy.The stage of cancer progression prior to the procedure was stage ii.Reportedly, the patient's target anatomy of the sigmoid was tortuous.The patient felt pain when the scope was advanced into the colon.According to the complainant, the hydra jagwire was placed at the stricture site after some difficulty advancing.The stent was advanced to the target site and the physician began releasing the stent but reconstrianed the stent once during the procedure.The physician then deployed the stent.Radiography was performed and no signs of free air were detected during stent deployment.However, after the stent was deployed, it was noted that the patient¿s abdomen was swelling.Ct scan was immediately performed and a perforation was confirmed at the distal end of the stent.Surgery was immediately performed to remove the stent and the tumor, including the perforated area.Post procedure, the patient was transferred from the icu to the general ward on an unknown date and was still under observation.According to the physician, it was unknown which of the devices caused the perforation or when the perforation occurred during the procedure.In the physician¿s assessment, manipulation of the devices contributed to the perforation since the anatomy was tortuous.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 3961521
• MDR Text Key: 4605929
• Report Number: 3005099803-2014-02648
• 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
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2016
• Device Model Number: M00565110
• Device Catalogue Number: 6511
• Device Lot Number: 0016879442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2014
• Initial Date FDA Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2014
• 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 Outcome(s): Required Intervention