MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER FLEXIMA¿ BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00539240
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 a flexima biliary stent was used in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during unpacking, it was observed that the sterile seal of the device was damaged and has an air leakage.The procedure was completed with another flexima biliary stent.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
A visual evaluation of the returned device found the stent attached and it remains secured with the suture.Residues were present on the device indicating use and handling.The packaging of the device was not present and not returned for analysis.The push catheter is slightly kinked in multiple locations.The suture hole is torn.Based on the product analysis, the reported event could not confirmed since the packaging of the device was not present and not returned for analysis.Regarding the analysis of the returned device itself, it was concluded that there were most likely some anatomical/procedural factors encountered during the procedure which may have limited the overall performance of the device.A device under tortuous conditions due to patient anatomy or customer use/manipulation/maneuvering can cause the device to bend/coil leading to kinks and bends in the stent or the catheters.Continued effort to deploy the stent likely caused tearing of the suture hole.In addition, the customer states that the issue was noted during unpacking, however, residues were present on the device indicating use and handling.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A lot history search was performed and found one other complaint against lot number 17928918 by the same customer due to a different reason.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during unpacking, it was observed that the sterile seal of the device was damaged and has an air leakage.The procedure was completed with another flexima biliary stent.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.".

• Brand Name: FLEXIMA¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6258034
• Report Number: 3005099803-2017-00075
• Device Sequence Number: 16158406
• Product Code: FGE
• UDI-Device Identifier: 08714729162551
• UDI-Public: (01)08714729162551(17)20180430(10)17928918
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K965147
• 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
• Report Date (Section B): 12/27/2016

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: 04/30/2018
• Device Model Number: M00539240
• Device Catalogue Number: 3924
• Device Lot Number: 17928918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2017
• Supplement Report FDA Received Date: 02/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1