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

Model Number M00565030

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

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

Event Date 09/09/2021

Event Type  Injury  

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 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 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.

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
• 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: 12882263
• MDR Text Key: 281322281
• Report Number: 3005099803-2021-06112
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2021
• 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
• Patient Outcome(s): Required Intervention