MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	H965430600
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on june 21, 2021 that a wallstent biliary stent was to be implanted to treat a malignant stricture in the common bile duct during a stenting procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent did not release and the white olive tip detached inside the patient.The stent was removed from the patient fully covered by the outer sheath and the detached tip was removed from the patient using a stone retrieval basket.The procedure was completed with another wallstent biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallstent biliary stent was to be implanted to treat a malignant stricture in the common bile duct during a stenting procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent did not release and the white olive tip detached inside the patient.The stent was removed from the patient fully covered by the outer sheath and the detached tip was removed from the patient using a stone retrieval basket.The procedure was completed with another wallstent biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: medical device problem code a0501 captures the reportable event of tip detached.Block h10: a wallstent biliary uncovered stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual examination was performed and it was observed that the outer sheath was returned slightly pushed out of the tip.Functional evaluation revealed the stent was deployed without resistance by actuating the delivery system (slide the handle back along the stainless steel tube).No other issues were noted to the stent and delivery system.The reported event of tip detached was not confirmed.The tip of the delivery system was returned in good condition and was attached to the inner sheath.The reported event of stent failure to deploy could not be confirmed; the stent was able to be deployed without resistance during functional analysis.The investigation concluded that the reported events and the observed problem were most likely due to anatomical factors such as patient's tight anatomy, limited the performance of the device and contributed to stent failure to deploy during the procedure.Additionally, it is possible that the physician perceived as "tip dismantled" was the outer sheath slightly pushed out of the tip.Taking all available information into consideration, the investigation concluded that there is not enough information to confirm the reported event as there is no confirmation on what the customer indicated.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/ product label.
Additional Manufacturer Narrative
Based on the additional information received on september 08, 2021.Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: medical device problem code a0501 captures the reportable event of tip detached.Block h10: a wallstent biliary uncovered stent and delivery system were returned for analysis.The stent was received fully covered and undeployed.Visual examination was performed and it was observed that the outer sheath was returned slightly pushed out of the tip.Functional evaluation revealed the stent was deployed without resistance by actuating the delivery system (slide the handle back along the stainless steel tube).No other issues were noted to the stent and delivery system.Taking all available information into consideration, the investigation concluded that the reported event of stent failure to deploy was most likely due to anatomical factors encountered during the procedure.It may be that due to patient's tight anatomy, limited the performance of the device and contributed to stent being unable to deploy.However, during functional analysis, the stent was able to be deployed without resistance.Taking all available information into consideration, the investigation concluded that there is not enough information to confirm the reported event as there is no confirmation on what the customer indicated.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu)/ product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(60 2021 that a wallstent biliary stent was to be implanted to treat a malignant stricture in the common bile duct during a stenting procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent did not release and the white olive tip detached inside the patient.The stent was removed from the patient fully covered by the outer sheath and the detached tip was removed from the patient using a stone retrieval basket.The procedure was completed with another wallstent biliary stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on september 8, 2021: it was reported that the tip did not detach and there was no intervention required.

• Brand Name: WALLSTENT BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12149834
• Report Number: 3005099803-2021-03386
• Device Sequence Number: 14640629
• Product Code: FGE
• UDI-Device Identifier: 08714729204688
• UDI-Public: 08714729204688
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K982184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2021

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: 11/12/2022
• Device Model Number: H965430600
• Device Catalogue Number: 3060
• Device Lot Number: 0026348388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/04/2021; 09/08/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 08/26/2021; 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention