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

Model Number M00565030

Device Problems Failure to Advance (2524); Difficult to Advance (2920); Appropriate Term/Code Not Available (3191)

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

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem 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 (b)(6) 2021 that a wallflex enteral duodenal stent was to be implanted to treat a malignant stricture in the duodenum from pancreatic mass during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the guidewire was unable to advance through the stent delivery system.A different stiffer guidewire was attempted but again the guidewire was unable to advance through the stent delivery system.The physician preloaded the stent into the scope with the guidewire; however, the delivery system was unable to advance and cross the stricture.The procedure was not completed and will be rescheduled where a shorter scope will be used.There were no patient complications reported as a result of this event.

• 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: 13112129
• MDR Text Key: 287197888
• Report Number: 3005099803-2021-08031
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2023
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0027741039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• 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