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

Model Number	M00565030
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on july 18, 2022 that a wallflex duodenal stent was to be implanted to treat an approximately 5 cm malignant stricture in the duodenum during an esophagogastroduodenoscopy (egd) with duodenal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous prior to stent placement.During the procedure, the wallflex duodenal stent was deployed in the correct location.During removal of the wallflex duodenal delivery system, the delivery system got caught on the wallflex duodenal stent.As the physician continued to withdraw the delivery system, the delivery system pulled the wallflex duodenal stent and eventually the wallflex duodenal stent moved out of place.The wallflex duodenal stent was removed from the patient with rat- tooth grasping forceps and a 22 x 90 wallflex duodenal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the wallflex duodenal stent was disposed and will not be returned for evaluation; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: WALLFLEX DUODENAL
• Common Device Name: 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: 15186628
• Report Number: 3005099803-2022-04294
• Device Sequence Number: 5847661
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2022

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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown