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

Model Number	M00569650
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2020
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)(6).(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 (b)(6) 2020 that a wallstent biliary rx uncovered stent was to be implanted to treat a malignant obstruction in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) with biliary duct metal implantation procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed.During removal of the delivery system, the catheter got stuck and could not be retrieved.The physician shook the delivery system and was able to remove the catheter from the patient.However, it was noticed thathe stent was displaced outward.The stent was removed with a snare and the procedure was completed with another wallflex biliary.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), 2020 that a wallstent biliary rx uncovered stent was to be implanted to treat a malignant obstruction in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) with biliary duct metal implantation procedure performed on (b)(6), 2020.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed.During removal of the delivery system, the catheter got stuck and could not be retrieved.The physician shook the delivery system and was able to remove the catheter from the patient.However, it was noticed thathe stent was displaced outward.The stent was removed with a snare and the procedure was completed with another wallflex biliary.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 e1: initial reporter's address 1: (b)(6).Block h6: problem code 3009 captures the reportable event of stent positioning issue.Problem code 1528 captures the reportable event of delivery system difficult to remove.Block h10: a wallstent biliary rx delivery system was received for analysis; the stent was not returned.The delivery system was returned with the shipping mandrel inserted.Visual examination of the returned device found the outer blue sheath was kinked approximately 46 cm from the tip of the delivery system.No other issues with device were noted.The reported event of stent positioning issue and delivery system difficult to remove could not be confirmed.It is not possible to replicate the failures occured during the procedure in the laboratory.The damage noted to the delivery system may have been a result of an excessive force applied to the device during removal of the delivery system.The investigation concluded that the reported events and the observed failure were likely due to factors encountered during the procedure.It may be how the device was handled or manipulated, and the anatomy of the patient, limited the performance of the device and contributed to the failure reported of delivery system getting stuck during withdrawal.Based on the information in the event description, the physician shook and retrieved the delivery system and this could cause the stent to displace.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/ product label.

• 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: 10171195
• Report Number: 3005099803-2020-02372
• Device Sequence Number: 2142822
• Product Code: FGE
• UDI-Device Identifier: 08714729296850
• UDI-Public: 08714729296850
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K012752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2020

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: 05/15/2021
• Device Model Number: M00569650
• Device Catalogue Number: 6965
• Device Lot Number: 0024773910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/15/2020
• 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