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

Model Number	M00539210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).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 a flexima biliary stent was used during endoscopic mucosal resection (emr) in the common bile duct performed on (b)(6) 2019.According to the complainant, during the procedure, when the physician attempted to deploy the stent into the common bile duct through forceps cana, the stent was unable to be released causing the stent to be broken.The broken stent was removed together with the catheter.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 noted to be stable.
Additional Manufacturer Narrative
Initial reporter facility address: (b)(6).Problem code 1069 captures for the reported event of stent broken.Product was returned and product analysis completed a visual evaluation of the returned a flexima biliary stent was returned for analysis, the guide catheter was observed stretched and detached in the proximal section, however, the stent was not returned for analysis, therefore, unable to confirm the as reported observation with testing of the product return; consequently, not confirming the reported complaint.Based on the product analysis, it is most likely that procedural or anatomical factors encountered during procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use can lead to guide catheter found broken and stretched, the continued attempts to retract the guide catheter or force applied to the device in order to release the stent can result in guide catheter broken and stretching.It was concluded that the investigation conclusion code of this event (stent break) is no problem detected since the device complaint or problem cannot be confirmed.The dhr review was performed and no anomalies were observed, 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.Updated: problem code 1069 captures for the reportable investigating results of guide catheter broken.
Event or Problem Description
It was reported to boston scientific corporation that a flexima biliary stent was used during endoscopic mucosal resection (emr) in the common bile duct performed on (b)(6) 2019.According to the complainant, during the procedure, when the physician attempted to deploy the stent into the common bile duct through forceps cana, the stent was unable to be released causing the stent to be broken.The broken stent was removed together with the catheter.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 noted to be stable.

• 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: 8771904
• Report Number: 3005099803-2019-03475
• Device Sequence Number: 1708012
• Product Code: FGE
• UDI-Device Identifier: 08714729162520
• UDI-Public: 08714729162520
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/21/2019

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: 11/04/2021
• Device Model Number: M00539210
• Device Catalogue Number: 3921
• Device Lot Number: 0022888888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 52