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

Model Number M00565060

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

Patient Problems Perforation (2001); No Code Available (3191)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: date of event was approximated to (b)(6) 2019 as no specific event date was reported.The complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.However, it was reported that the device was not used past its expiry date.(b)(4).The complainant indicated that the suspect device remains implanted 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 june 26, 2019 that a wallflex colonic stent has been implanted in the colon to treat an obstruction during a stent placement procedure performed on (b)(6) 2019.Reportedly, the stent was placed for decompression before a scheduled resection and the procedure went well.According to the complainant, on an unknown date, the patient presented back to the hospital with a perforated diverticulitis.There was no reported issue with the stent and it is unknown whether there is a relationship between the stent and the perforated diverticulitis.A surgery was performed but it is unknown when the surgery occurred or what it entailed.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.

• 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: 8808091
• MDR Text Key: 151612189
• Report Number: 3005099803-2019-03621
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2019
• 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): Hospitalization; Required Intervention