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

Model Number	M00565030
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientfiic corporation on (b)(6) 2021 that a wallflex enteral duodenal stent was used for stones extraction during endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2021.During the procedure, there was difficulty in placing the stent in the target location.The stent was removed and the procedure was reported to be successfully completed.There were no patient complications reported as a result of this event.Note: it was reported that the wallflex enteral duodenal stent was used for stones extraction.However, wallflex duodenal stent system with anchor lock delivery system directions for use (dfu), the device is used for palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.
Event or Problem Description
It was reported to boston scientfiic corporation on (b)(6), 2021 that a wallflex enteral duodenal stent was used for stones extraction during endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6), 2021.During the procedure, there was difficulty in placing the stent in the target location.The stent was removed and the procedure was reported to be successfully completed.There were no patient complications reported as a result of this event.**additional information received on february 03, 2022 and february 07, 2022** the stent was implanted in the duodenum to treat a duodenal stenosis.The patient was then treated for stones in the bile duct.
Additional Manufacturer Narrative
Blocks b5 and h6 (device codes) have been updated with additional information received on february 03, 2022 and february 07, 2022.Block h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, 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: 12882263
• Report Number: 3005099803-2021-06112
• Device Sequence Number: 11968926
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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: 06/08/2023
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0027451711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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