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

Model Number UNK-P-WALLFLEX_ENTERAL_STENT

Device Problems Defective Device (2588); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to be (b)(6) 2018 as no specific event date was reported.The complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the stent remains implanted and the catheter 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex colonic stent has been implanted to treat a malignant stricture in the colon due to colon cancer during a stent placement procedure performed on an unknown date.According to the complainant, during the procedure, it was noted that there was no "point of no return" marker or white line on the handle of the device to use as reference during stent deployment.The stent was deployed without fluoroscopy, and reportedly was imprecisely positioned.Reportedly, the stent remains implanted and another wallflex colonic stent was used to bridge the first stent to complete the procedure.There were no patient complications 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 7891682
• MDR Text Key: 120823439
• Report Number: 3005099803-2018-60499
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062750
• 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: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK-P-WALLFLEX_ENTERAL_STENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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