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

Model Number	M00547010
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 the an extractor pro rx retrieval balloon was used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device experienced difficulty advancing down the endoscope.It was noted that the device never left the scope.Upon removal of the device, the catheter seemed to have been cut horizontally above the radiopaque marker, and the balloon was noted to be torn.A photo sent by the customer confirmed the catheter break, as well as a kink on the catheter.The procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 1069 captures the reportable issue of catheter broken.Block h10: a visual examination of the returned complaint device found that the distal tip of the catheter, including the balloon was detached from the rest of the device.The detached section was not returned with the device.It was also noted that the distal end of the rx channel was torn.The catheter was noted to be kinked.Functional analysis was unable to be performed due to the condition of the device.This failure is most likely that procedural or anatomical 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 could have caused the reported failure of the catheter being broken.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 the an extractor pro rx retrieval balloon was used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device experienced difficulty advancing down the endoscope.It was noted that the device never left the scope.Upon removal of the device, the catheter seemed to have been cut horizontally above the radiopaque marker, and the balloon was noted to be torn.A photo sent by the customer confirmed the catheter break, as well as a kink on the catheter.The procedure was completed with another extractor pro rx retrieval balloon.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: 9612138
• Report Number: 3005099803-2020-00096
• Device Sequence Number: 18979021
• Product Code: FGE
• UDI-Device Identifier: 08714729790297
• UDI-Public: 08714729790297
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/31/2020

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: 09/22/2021
• Device Model Number: M00547010
• Device Catalogue Number: 4701
• Device Lot Number: 0024474536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 12/24/2019
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1