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

Model Number	M00534680
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device remains implanted 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after the pull wire was retracted, the physician had difficulty removing the guidewire from the patient, when attempted to pull the guidewire with force, the guidewire was managed to be removed from the stent.However, due to the maneuver, the guidewire lost its ptfe coating in proximity of the exit port and was blocked inside the guide catheter.Reportedly, the suture was stuck and the stent had a break in the vicinity of the fin due to the maneuver yet the advanix biliary stent was implanted successfully.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was noted to be good.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after the pull wire was retracted, the physician had difficulty removing the guidewire from the patient, when attempted to pull the guidewire with force, the guidewire was managed to be removed from the stent.However, due to the manuever, the guidewire lost its ptfe coating in proximity of the exit port and was blocked inside the guide catheter.Reportedly, the suture was stuck and the stent had a break in the vicinity of the fin due to the manuever yet the advanix biliary stent was implanted successfully.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was noted to be good.Additional information recieved on 25sep2019.The plastic stent was removed as a routine procedure and no other stent was implanted as patient illness was solved.Stent indwell was approximately one month, one month and a half.Patient repeated ercp for stent removal not because of symptoms but for hospital protocol.
Additional Manufacturer Narrative
Problem code 1069 captures for the reported event of stent broken.Product analysis: a visual evaluation of an advanix rx delivery system was performed, a guidewire was found stuck on the delivery system, the guidewire stuck was not completely retracted from the delivery system, however, there was no bent/kinks to along of the device, also, the suture and the suture hole do not have any visual issue.The reported complaint issue of stent break and the suture deployment issue cannot be confirmed since the stent was not returned for analysis.A functional inspection was performed, the guidewire could not be removed from the delivery system, it was stuck due to the coating at distal section of the guidewire was buckled/damaged which caused the guidewire caught in the delivery system.Based on the product analysis, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance.Handling and manipulation of the guidewire during its use could have damage the coating, also interaction with another devices/instruments could have damaged the guidewire, once the guidewire coating is damaged, this condition will affect the overall performance of the devices, the coating buckled/damaged would cause issues to advance/remove the guidewire from the delivery system, which contributed with the reported issue of device difficult to withdraw guidewire issue.Additionally, the guidewire stuck is not completely retracted from the delivery system this device condition could have generated the reported complaint issue of stent difficult to deploy.Therefore the most probable root cause for this event is 'adverse event related to procedure' since the adverse events occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed, no anomaliesobserved, the review confirmed that the accepted device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.
Additional Manufacturer Narrative
Block f10; h6: problem code 1069 captures for the reported event of stent broken.Block h10: product analysis a visual evaluation of an advanix rx delivery system was performed, a guidewire was found stuck on the delivery system, the guidewire stuck was not completely retracted from the delivery system, however, there was no bent/kinks to along of the device, also, the suture and the suture hole do not have any visual issue.The reported complaint issue of stent break and the suture deployment issue cannot be confirmed since the stent was not returned for analysis.A functional inspection was performed, the guidewire could not be removed from the delivery system, it was stuck due to the coating at distal section of the guidewire was buckled/damaged which caused the guidewire caught in the delivery system.Based on the product analysis, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance.Handling and manipulation of the guidewire during its use could have damage the coating, also interaction with another devices/instruments could have damaged the guidewire, once the guidewire coating is damaged, this condition will affect the overall performance of the devices, the coating buckled/damaged would cause issues to advance/remove the guidewire from the delivery system, which contributed with the reported issue of device difficult to withdraw guidewire issue.Additionally, the guidewire stuck is not completely retracted from the delivery system this device condition could have generated the reported complaint issue of stent difficult to deploy.Therefore the most probable root cause for this event is 'adverse event related to procedure' since the adverse events occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed, no anomaliesobserved, the review confirmed that the accepted device met all manufacturing specifications and boston scientific manufacturing processes include extensive inspections to ensure that all finished devices meet specifications.Block e1: initial reporter state updated to na.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after the pull wire was retracted, the physician had difficulty removing the guidewire from the patient, when attempted to pull the guidewire with force, the guidewire was managed to be removed from the stent.However, due to the manuever, the guidewire lost its ptfe coating in proximity of the exit port and was blocked inside the guide catheter.Reportedly, the suture was stuck and the stent had a break in the vicinity of the fin due to the manuever yet the advanix biliary stent was implanted successfully.There were no patient complications reported as a result of this event.The condition of the patient at the conclusion of the procedure was noted to be good.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8846402
• Report Number: 3005099803-2019-03884
• Device Sequence Number: 2447565
• Product Code: FGE
• UDI-Device Identifier: 08714729787235
• UDI-Public: 08714729787235
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: IT
• PMA/510(K) Number: K101314
• 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,Followup
• Report Date (Section B): 10/16/2019

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: 03/11/2020
• Device Model Number: M00534680
• Device Catalogue Number: 3468
• Device Lot Number: 0021847602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 09/03/2019; 09/25/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/24/2019; 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1