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

Model Number	M00534340
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2022 as no event date was reported.Initial reporter address: (b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem 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 that an advanix biliary stent was used during a procedure.The event date was not reported.During the procedure, when the advanix biliary stent was attempted to deploy, it was felt that the guide catheter became tense and release was complicated.The procedure was successfully completed with another advanix biliary stent.A photo of the complaint device was provided and showed that the guide catheter was detached.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during a procedure.The event date was not reported.During the procedure, when the advanix biliary stent was attempted to deploy, it was felt that the guide catheter became tense and release was complicated.The procedure was successfully completed with another advanix biliary stent.A photo of the complaint device was provided and showed that the guide catheter was detached.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6), 2022 as no event date was reported.Block e1: initial reporter address: av.Cordillera de los alpes 990 block h6: medical device code a0401 captures the reportable event of guide catheter broken.Block h10: the returned advanix rx biliry preloaded stent was analyzed, and a visual evaluation noted that the device returned without the stent and the suture thread.During the product analysis, it was observed that the pull wire was retracted until it passed the not return point.It was necessary to perform a destructive inspection and it was determined that the guide catheter was properly attached to the pull wire, and it was not broken.A microscopic inspection was performed and it was found that the push catheter suture hole was torn.No other issues with the device were noted.The reported event was not confirmed.There was no enough evidence to determine the detachment of the suture thread and a failure to deploy the stent.It was found that the guide catheter was not broken, and the pull wire has passed the point of no return, so it is possible that the functionality of the device could have been affected in some way, it could have been by manipulation, technique used or the anatomical conditions of the patient.The torn in the suture hole of the push catheter suggest an excess of tension in the suture at the time of using the device.However, no issues were found on the returned device that may have caused the reported event.The product record review confirmed that this is not a new failure type and the risk is anticipated.Therefore, the as reported codes suture detachment of device or device component, stent failure to deploy and catheter guide break could not be confirmed and were assigned as no problem detected.As no reported allegation catheter push suture hole torn was added with the cause code adverse event related to procedure.Block h11: updated the following block d4: model number, lot number, catalog number and expiration date.
Additional Manufacturer Narrative
Block b3: date of event was approximated to june 01, 2022 as no event date was reported.Block e1: initial reporter address: (b)(6).Block h6: medical device code a0401 captures the reportable event of guide catheter broken.Block h10: the returned advanix naviflex delivery system was analyzed, and a visual evaluation noted that the pull wire did not pass the no return point, so it was necessary to perform a destructive analysis to evaluate the guide catheter and it was found that it was not broken.A microscopic inspection was performed, and there were no possible problems observed.That the pull wire passed the not return point and the stent and the suture thread were not present in the picture.The push catheter was cut to expose or to inspect the internal components and it was determined that the guide catheter was properly attached to the pull wire.No other problems with the device were noted.The reported event was not confirmed.The returned part of the device and the image provided do not offer sufficient evidence to be able to claim that the reported failures occurred due to the influence of the device.It is possible that the functionality of the device could have been affected in some way, by manipulation, technique used or the anatomical conditions of the patient.However, since the suture and the stent did not return, and the guide catheter was not broken, the reported codes cannot be confirmed and were assigned with the cause code "no problem detected".Therefore, the product record review confirmed that this is not a new failure type, and the risk is anticipated.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during a procedure.The event date was not reported.During the procedure, when the advanix biliary stent was attempted to deploy, it was felt that the guide catheter became tense, and release was complicated.The procedure was successfully completed with another advanix biliary stent.A photo of the complaint device was provided and showed that the guide catheter was detached.There were no patient complications reported as a result of this event.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15064832
• Report Number: 3005099803-2022-03715
• Device Sequence Number: 5504698
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: 08714729787433
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2022

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: 08/01/2019
• Device Model Number: M00534340
• Device Catalogue Number: 3434
• Device Lot Number: 0020955374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 09/02/2022; 10/07/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/30/2022; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown