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

Model Number M00565120

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2019

Event Type  Injury  

Manufacturer Narrative

Patient's exact weight is unknown; however it was reported that the patient's body mass index is 27.68 kg/m2.(b)(4).The complainant indicated that the fragment was disposed of and the stent 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

It was reported to boston scientific corporation on january 10, 2020 that a wallflex colonic stent has been implanted in the colon to treat an extrinsic severe stenosis measuring 1 cm in length x 7 mm in diameter located at 30 cm proximal to the anus during a gastrointestinal stent placement procedure performed on (b)(6) 2019.According to the complainant, post stent placement, the physician noticed that a part of the delivery catheter was sheared off and was left inside the stent lumen.The fragment was successfully removed with biopsy forceps and the stent remains implanted.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 9656112
• MDR Text Key: 177399217
• Report Number: 3005099803-2020-00220
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456599
• UDI-Public: 08714729456599
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2020
• Device Model Number: M00565120
• Device Catalogue Number: 6512
• Device Lot Number: 0022766941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2018
• 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
• Patient Age: 82 YR