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

Model Number	M00570660
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	03/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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) 2019 that a wallflex biliary rx uncovered stent has been implanted in the hilar region due to cholangiocarcinoma during a duodenoscopy with bilateral biliary stenting procedure performed on (b)(6) 2019.Reportedly, a non-bsc stent had been implanted in the left side and the wallflex biliary rx uncovered stent was being implanted on the right side.According to the complainant, during the procedure, there was difficulty deploying the stent due to the very tight stricture.Eventually, the stent was able to be deployed; however, the delivery system could not be removed through the stent and from the patient.Reportedly, the physician shook and stretched the delivery system in the attempt to release the delivery system from the stent, but, it was unsuccessful.The physician cut the handle part of the delivery system, the rest of the delivery system was brought through the patient's nose and left within the patient, and the procedure was ended.Reportedly, the physician planned to remove the delivery system in another procedure.The patient was then sent to intensive care unit for observation due to chronic pancreatitis.Reportedly, as of (b)(6) 2019, the patient's condition was "severe pancreatitis" and the delivery system had not been removed yet.On (b)(6) 2019, the delivery system was removed successfully while removing the patient's nasogastric tube.
Additional Manufacturer Narrative
Block b5 has been updated based on additional information received on april 17, 2019.Block h6: patient code 1932 captures the reportable event of pancreatitis.Problem code 1528 captures the reportable event of delivery system difficult to remove.Block h10: the device was disposed of by the complainant and was not returned for analysis.An investigation was completed based on a review of the photo of the delivery system that was provided by the complainant.The photo shows the clear outer sheath was kinked and buckled.This type of damage is consistent with the application of force during attempted deployment, and may have contributed to the reported difficulty deploying.Based on analysis of all available information, the investigation concluded that the failures observed in the photo and reported by the complainant may have been due to anatomical or procedural factors, including the characteristics of the lesion, handling of the device, technique of the user, which limited the performance of the device.Therefore, the most probable cause of the event 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.
Event or Problem Description
It was reported to boston scientific corporation on march 11, 2019 that a wallflex biliary rx uncovered stent has been implanted in the hilar region due to cholangiocarcinoma during a duodenoscopy with bilateral biliary stenting procedure performed on (b)(6) 2019.Reportedly, a non-bsc stent had been implanted in the left side and the wallflex bilairy rx uncovered stent was being implanted on the right side.According to the complainant, during the procedure, there was difficulty deploying the stent due to the very tight stricture.Eventually, the stent was able to be deployed; however, the delivery system could not be removed through the stent and from the patient.Reportedly, the physician shook and stretched the delivery system in the attempt to release the delivery system from the stent, but, it was unsuccessful.The physician cut the handle part of the delivery system, the rest of the delivery system was brought through the patient's nose and left within the patient, and the procedure was ended.Reportedly, the physician planned to remove the delivery system in another procedure.The patient was then sent to intensive care unit for observation due to chronic pancreatitis.Reportedly, as of march 15, 2019, the patient's condition was "severe pancreatitis" and the delivery system had not been removed yet.On march 18, 2019, the delivery system was removed successfully while removing the patient's nasogatric tube.According to the complainant, the patient's pancreatitis was acute and was a post-ercp complication.The patient did not have a history of chronic pancreatitis.The wallflex biliary stent may have been associated with the pancreatitis, which may have been a persistent complication of pancreatic duct opening.The complainant provided a photograph of the delivery system after it was removed from the patient, which revealed that the clear outer sheath was kinked and buckled.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8491199
• Report Number: 3005099803-2019-01535
• Device Sequence Number: 1921902
• Product Code: FGE
• UDI-Device Identifier: 08714729759287
• UDI-Public: 08714729759287
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2019

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: 12/20/2020
• Device Model Number: M00570660
• Device Catalogue Number: 7066
• Device Lot Number: 0023114598
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/14/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR