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

Model Number	M00547010
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon device was used in the colon during a colonic stent procedure performed on (b)(6) 2021.During the procedure, the distal tip of the catheter unknowingly detached inside the scope.The procedure was completed successfully at this time.It was only discovered during routine cleaning of the scope after the procedure when water could not be flushed through the scope; reportedly, a guidewire was then placed inside the working channel which removed the detached tip from the scope.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of distal tip detached.Block h10: investigation result a visual examination of the returned complaint device found the balloon shaft/lumen was torn.The distal tip of the device, including the balloon, was detached from the device and was not returned.This confirms the reported event of the distal tip detaching.Functional analysis of the device could not be performed due to the condition of the returned device.This failure is likely due to factors encountered during the procedure, such as handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure that could have possibly affected the device performance 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 rx retrieval balloon device was used in the colon during a colonic stent procedure performed on (b)(6) 2021.During the procedure, the distal tip of the catheter unknowingly detached inside the scope.The procedure was completed successfully at this time.It was only discovered during routine cleaning of the scope after the procedure when water could not be flushed through the scope; reportedly, a guidewire was then placed inside the working channel which removed the detached tip from the scope.There were no patient complications reported as a result of this event.

• Brand Name: EXTRACTOR PRO RX
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11329817
• Report Number: 3005099803-2021-00484
• Device Sequence Number: 16405524
• Product Code: FGE
• UDI-Device Identifier: 08714729790297
• UDI-Public: 08714729790297
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021

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: 08/12/2022
• Device Model Number: M00547010
• Device Catalogue Number: 4701
• Device Lot Number: 0025849182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1