MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565030

Device Problems Positioning Failure (1158); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Imdrf device code a0501 captures the reportable event of tip detached.

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was used to treat a 4-5mm stricture in the duodenum during a fibroscopy with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous.During the procedure, the stent was blocked when being deployed and the olive tip broke.The procedure was completed with another wallflex duodenal stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Blocks b5 and h6 (device codes) have been updated with additional information received on april 04, 2023.Block e1: the initial reporter's city is (b)(6) block h6: imdrf device code a0501 captures the reportable event of tip detached.

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was used to treat a 4-5mm stricture in the duodenum during a fibroscopy with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous.During the procedure, the stent was blocked when being deployed and the olive tip broke.The procedure was completed with another wallflex duodenal stent.There were no patient complications reported as a result of this event.Additional information received on april 04, 2023 the physician had a feeling that the distal olive tip broke; however, when the device was visually checked, there were no visible problems noted on the olive tip.

• Brand Name: WALLFLEX DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• 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: 16620683
• MDR Text Key: 312102455
• Report Number: 3005099803-2023-01605
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2023
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0027435211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 04/04/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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