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

Model Number	M00569660
Medical Device Problem Codes	Failure to Advance (2524); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's exact age was not reported, however, the patient was reported to be over the age of 18.(b)(4).The device has been received for analysis.Upon completion of the failure 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 may 26, 2021 that a wallstent biliary rx uncovered stent was to be implanted to treat a 1.5cm malignant obstruction in the middle and upper common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to cross the lesion.The stent was fully covered on the delivery system when it was removed from the patient.Reportedly, the patient felt discomfort and the procedure was cancelled.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 rx uncovered stent was to be implanted to treat a 1.5cm malignant obstruction in the middle and upper common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6), 2021.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to cross the lesion.The stent was fully covered on the delivery system when it was removed from the patient.Reportedly, the patient felt discomfort and the procedure was cancelled.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: the patient's exact age was not reported, however, the patient was reported to be over the age of 18.Block h6: medical device problem a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: a wallstent biliary rx uncovered stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection on the delivery system was performed and no visual issues/damages were noted.Taking all available information, the stent received did not show evidence of the reported event of delivery system difficult to cross lesion or any defect that could have contributed to the event.Additionally, the reported patient complication of discomfort could not be visually/functionally verified since it is a clinical effect of the procedure; therefore, it is not confirmed.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.

• Brand Name: WALLSTENT RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12033736
• Report Number: 3005099803-2021-02885
• Device Sequence Number: 11615821
• Product Code: FGE
• UDI-Device Identifier: 08714729296867
• UDI-Public: 08714729296867
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K012752
• 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
• Report Date (Section B): 07/12/2021

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: 12/23/2021
• Device Model Number: M00569660
• Device Catalogue Number: 6966
• Device Lot Number: 0025634606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1