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

Model Number	M00547110
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Investigation result: visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.Microscopic inspection was done and found that the tip of the device detached.Functional analysis was performed, and the balloon could not be inflated due to the tip was detached.It is possible that interaction with scope or any other surface during the procedure could create friction on the catheter, causing the issue found of distal tip detached during the procedure.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.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was used in the prone position during a cholangiopancreatography procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon burst.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 stable.Investigation results revealed that the distal tip detached/separated; therefore, this is now an mdr reportable event.

• 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: 11236342
• Report Number: 3005099803-2021-00236
• Device Sequence Number: 3842301
• Product Code: FGE
• UDI-Device Identifier: 08714729790402
• UDI-Public: 08714729790402
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 01/27/2021

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: 11/19/2021
• Device Model Number: M00547110
• Device Catalogue Number: 4711
• Device Lot Number: 0024801241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR