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

Model Number	3932
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exact patient age unknown, but reported to be over 18 years of age.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr report # 3005099803-2019-03911 and mfr.Report # 3005099803-2019-03910).It was reported to boston scientific corporation that two previously implanted flexima biliary stents were removed from a patient during an endoscopic biliary drainage with stent exchange procedure performed on (b)(6) 2019.The exact implant dates for the flexima stents were not reported.The patient had a previously placed a flexima biliary stent 10fr/10cm in b6, and a flexima biliary stent 10fr/15cm in b8.Both stents were reported to be occluded.The physician removed the occluded stents using a snare.The physician attempted to place a new flexima biliary stent 10fr/15cm in b8, however the device became difficult to advance in the patient's anatomy due to severe tortuosity.The device was pulled out to change the guidewire.The guidewire was replaced and the physician attempted again to place the flexima biliary stent 10fr/15cm in b8 however the stent prematurely deployed from the delivery system.Upon removal and examination of the flexima biliary stent 10fr/15cm, the suture was noted to be separated and remained inside the working channel of the endoscope.The delivery system in which stent was not attached was inserted through the hydrajag, then it was pushed, and placement was completed with the flexima biliary stent 10fr/15cm.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIMA BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8862167
• Report Number: 3005099803-2019-03911
• Device Sequence Number: 16274884
• Product Code: FGE
• UDI-Device Identifier: 08714729162636
• UDI-Public: 08714729162636
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/05/2019

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 Model Number: 3932
• Device Catalogue Number: 3932
• Device Lot Number: M00539320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1