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

Model Number	M00565010
Medical Device Problem Codes	Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The wallflex duodenal stent has not been received for analysis.Upon receipt and completion of the device 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 scientific corporation on july 13, 2022 that a wallflex duodenal stent was to be implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the wallflex duodenal stent looked normal when it was loaded over the guidewire and when the wallflex duodenal stent was deployed inside the patient.After removal of the wallflex duodenal stent delivery system, an x-ray was taken and the wallflex duodenal stent was not present inside the patient.The wallflex duodenal stent was found on the procedure room floor.A second attempt was made, but the wire was unable to be advanced.The procedure was completed with another wallflex duodenal stent.There were no patient complications as a result of this event.The patient condition after the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation on july 13, 2022 that a wallflex duodenal stent was to be implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, the wallflex duodenal stent looked normal when it was loaded over the guidewire and when the wallflex duodenal stent was deployed inside the patient.After removal of the wallflex duodenal stent delivery system, an x-ray was taken and the wallflex duodenal stent was not present inside the patient.The wallflex duodenal stent was found on the procedure room floor.A second attempt was made, but the wire was unable to be advanced.The procedure was completed with another wallflex duodenal stent.There were no patient complications as a result of this event.The patient condition after the procedure was reported to be stable.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: medical device problem code a150103 captures the reportable event of wallflex duodenal stent deployed prematurely outside the patient.Block h10: a wallflex duodenal stent and delivery system were returned for analysis.The stent was received fully deployed.Visual inspection was performed and found the outer blue sheath and the outer clear sheath were kinked and the inner tube was bent.Functional examination revealed that the 0.035" guidewire was inserted without any resistance.No other issues were noted to the stent and delivery system.The damages noted to the delivery system were most likely due to factors encountered during the procedure.Handling and excessive manipulation of the device without enough care could result to outer sheath kinked and inner tube bend.The reported event of stent premature deployment and difficulty advancing the guidewire could not be confirmed.These events are related to the procedure, therefore they could not be functionally/visually verified.Additionally, during functional examination, the guidewire was able to be inserted without any resistance.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A product labeling review identified that the device was used per the directions for use (dfu) / product label.

• 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: 15124751
• Report Number: 3005099803-2022-04163
• Device Sequence Number: 7381992
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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: 02/18/2024
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 0028895069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2022
• 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