MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXTRACTOR PRO XL; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00547110
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2019
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 an extractor pro xl retrieval balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the catheter broke in half.Reportedly, no part of the device detached in the patient, and the catheter was safely removed.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Problem code 1069 captures the reportable event of catheter break.Investigation result a visual examination of the returned complaint device revealed that the balloon did not have any visual defects.The catheter was noted to be broken in half, and the detached section was returned with the device.Functional evaluation could not be performed due to the condition of the returned device.This failure is likely due to factors or conditions related to procedure, the patient anatomy and/or the manner as the device was handled that could have affected its performance and its intended purpose.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the catheter broke in half.Reportedly, no part of the device detached in the patient, and the catheter was safely removed.The procedure was completed with another extractor pro xl retrieval balloon.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.

• Brand Name: EXTRACTOR PRO XL
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8838120
• Report Number: 3005099803-2019-03782
• Device Sequence Number: 2742441
• Product Code: FGE
• UDI-Device Identifier: 08714729790402
• UDI-Public: 08714729790402
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102082
• 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): 09/09/2019

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: 04/29/2021
• Device Model Number: M00547110
• Device Catalogue Number: 4711
• Device Lot Number: 0023719541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1