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

Model Number	M00534320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2019.According to the complainant, during the procedure, the guide catheter was completely retracted during the stent deployment attempt, however the suture was stuck between the pusher and stent which causes the deployment failure.Reportedly, the endoscope was pulled out of the patient including the stent and delivery system and it was noticed that the guide catheter was broken.The procedure was completed with another advanix-naviflex biliary stent.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable and good.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2019.According to the complainant, during the procedure, the guide catheter was completely retracted during the stent deployment attempt, however the suture was stuck between the pusher and stent which causes the deployment failure.Reportedly, the endoscope was pulled out of the patient including the stent and delivery system and it was noticed that the guide catheter was broken.The procedure was completed with another advanix-naviflex biliary stent.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable and good.
Additional Manufacturer Narrative
Problem code and device code 1069 captures the reportable event of guide catheter broken.Initial reporter phone:(b)(4).Investigation analysis an advanix preloaded stent was returned for analysis and found that the suture push hole and the stent suture hole were found torn additionally, kinks were found to along if the delivery system, the suture was not returned for analysis.It was confirmed that the guide catheter was detached and it was not returned for analysis, it's important to mention that the stent was returned unload of the delivery system and not other issues were found.The investigation concluded that it is most likely that during procedure the device could have been manipulated, since these failure found are issues that could have been generated by manipulation of the device by the user, also interaction with other devices such as a guidewire might have impacted the integrity of the device during the procedure.Handling and manipulation of the device during its use can contribute to these encountered failures, it's important to mention that this device condition could have generated the suture loose and the found guide catheter detached issue.This condition could cause problems with the stent, such as the failure to deploy reported issue.Therefore, 'adverse event related to procedure' is seleted as the most probable root cause for the complaint.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.Expiration date: 05/05/2021.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2019.According to the complainant, during the procedure, the guide catheter was completely retracted during the stent deployment attempt, however the suture was stuck between the pusher and stent which causes the deployment failure.Reportedly, the endoscope was pulled out of the patient including the stent and delivery system and it was noticed that the guide catheter was broken.The procedure was completed with another advanix-naviflex biliary stent.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.The condition of the patient at the conclusion of the procedure was reported to be stable and good.
Additional Manufacturer Narrative
Problem code and device code 1069 captures the reportable event of guide catheter broken.Initial reporter phone: (b)(6).Investigation analysis: an advanix preloaded stent was returned for analysis and found that the suture push hole and the stent suture hole were found torn additionally, kinks were found to along if the delivery system, the suture was not returned for analysis.It was confirmed that the guide catheter was detached and it was not returned for analysis, it's important to mention that the stent was returned unload of the delivery system and not other issues were found.The investigation concluded that it is most likely that during procedure the device could have been manipulated, since these failure found are issues that could have been generated by manipulation of the device by the user, also interaction with other devices such as a guidewire might have impacted the integrity of the device during the procedure.Handling and manipulation of the device during its use can contribute to these encountered failures, it's important to mention that this device condition could have generated the suture loose and the found guide catheter detached issue.This condition could cause problems with the stent, such as the failure to deploy reported issue.Therefore, 'adverse event related to procedure' is seleted as the most probable root cause for the complaint.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.

• 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: 9138714
• Report Number: 3005099803-2019-04796
• Device Sequence Number: 16796100
• Product Code: FGE
• UDI-Device Identifier: 08714729787419
• UDI-Public: 08714729787419
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2019

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: 05/05/2021
• Device Model Number: M00534320
• Device Catalogue Number: 3432
• Device Lot Number: 0023744883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 10/22/2019; 11/18/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/11/2019; 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 60