MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565050

Device Problems Premature Activation (1484); Failure to Advance (2524); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

The patient's exact age was not reported, however, the patient was reported to be under the age of 18.(b)(4).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.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2020-06375 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex colonic stent was to be implanted to treat an approximately 6cm malignant colonic obstruction in the sigmoid colon during a colonoscopy with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, post patient sedation, the physician had difficulty passing the delivery system over the guidewire and had difficulty advancing the delivery system towards the anatomy.Reportedly, the dreamwire guidewire (the subject of mfr.Report# 3005099803-2020-06375) got kinked.The physician wanted to exchange the guidewire; however, when the physician attempted to remove the stent from the scope, the wallflex colonic stent (the subject of this report) deployed prematurely inside the scope.The stent was removed and the procedure was not completed as another stent was unavailable.There were no patient complication reported as a result of this event.

• Brand Name: WALLFLEX COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11100447
• MDR Text Key: 224536159
• Report Number: 3005099803-2020-06471
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2022
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0025861163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2020
• 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