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

Model Number	M00565020
Medical Device Problem Codes	Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of seal compromised.
Event or Problem Description
Note: this report pertains to one of two devices to be used during the same procedure.Refer to manufacturer report # 3005099803-2023-03453 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2023, that two wallflex duodenal stent was to be used to treat a 7 mm duodenal tumor malignant obstruction in the duodenum during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During procedure, it was noted that the inner sterile packaging seal was compromised (the subject of this report).A different size wallflex duodenal stent (the subject of mfr.Report # 3005099803-2023-03453) was opened and the inner packaging seal was also compromised.A non-boston scientific device was used to complete the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
Note: this report pertains to one of two devices to be used during the same procedure.Refer to manufacturer report # 3005099803-2023-03452 and 3005099803-2023-03453 for the associated device information.It was reported to boston scientific corporation on june 07, 2023, that two wallflex duodenal stent was to be used to treat a 7 mm duodenal tumor malignant obstruction in the duodenum during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2023.During procedure, it was noted that the inner sterile packaging seal was compromised (the subject of this report).A different size wallflex duodenal stent (the subject of mfr.Report # 3005099803-2023-03453) was opened and the inner packaging seal was also compromised.A non-boston scientific device was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of seal compromised.Block h10: a wallflex enteral stent and delivery system were received for analysis; the packaging was not returned.The stent was received fully covered by the outer sheath and undeployed.Visual examination of the returned device found the stainless steel separated, the outer blue sheath was bent in different sections, and the outer clear sheath was also found kinked.No other problems were noted with the stent and delivery system.The investigation concluded that the observed failures of stent undeployed, stainless steel separated, outer blue sheath bent, and outer clear sheath kinked were likely due to factors encountered during the procedure.It may be that handling of the device and/or the technique used by the physician (force applied), limited the performance of the device and contributed to the observed failures.The reported event of packaging seal compromised was not confirmed.Based on the available information, there is not enough information to confirm the reported event of packaging seal compromised as the packaging was not returned with the device; therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

• 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: 17198328
• Report Number: 3005099803-2023-03452
• Device Sequence Number: 20229092
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 08/23/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0027461281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2021
• 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
• Patient Sex: Unknown