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

Model Number M00565100

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2016

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4).The complainant indicated that the 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 medwatch will be filed.

Event Description

Note: this manufacturer report pertains to one of two devices used in the same procedure.Refer to manufacturer report # 3005099803-2016-03943 and 3005099803-2016-03942 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2016 that two wallflex enteral colonic stents were to be placed in the large intestine during a lower gastrointestinal stent placement procedure performed on (b)(6) 2016.Reportedly, the stent was being implanted as palliative care due to the patient¿s cancer of the large intestine.According to the complainant, during the procedure, the first wallflex enteral colonic stent (the subject of mfr report # 3005099803-2016-03943) unintentionally deployed at an incorrect location (distally to oral side).The first stent was left implanted and the physician attempted to use a second wallflex enteral colonic stent (the subject of mfr report # 3005099803-2016-03942).The physician began deploying the second wallflex enteral colonic stent, but when the stent was halfway released it inadvertently fully deployed.The physician also left this stent implanted and then placed an ileus tube to complete the procedure.

• Brand Name: WALLFLEX¿ COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6200118
• MDR Text Key: 63177069
• Report Number: 3005099803-2016-03943
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/22/2016
• 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