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

Model Number	M00547300
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
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 a extractor pro rx-s retrieval balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon would not completely deflate even when the syringe was moved all the way back.Reportedly, the syringe was removed and refilled.The procedure was completed at this time.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a extractor pro rx-s retrieval balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon would not completely deflate even when the syringe was moved all the way back.Reportedly, the syringe was removed and refilled.The procedure was completed at this time.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code a1401 captures the reportable event of balloon failed to deflate.Block h10: visual and microscope inspection of the returned device revealed that the catheter was bent close to the balloon.No damages were noted on the balloon portion of the device.Functional analysis cannot be performed due to the balloon lumen being occluded and could not be unblocked, likely due to dry contrast.This failure is likely due to factors encountered during the procedure that the device had a catheter bent close to the balloon portion of the device as a result of any force applied in the catheter and probably as a result of this bent and the position of the balloon the device could not deflate in 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.

• Brand Name: EXTRACTOR PRO RX-S
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11877623
• Report Number: 3005099803-2021-02413
• Device Sequence Number: 1060048
• Product Code: FGE
• UDI-Device Identifier: 08714729907138
• UDI-Public: 08714729907138
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

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: 02/15/2023
• Device Model Number: M00547300
• Device Catalogue Number: 4730
• Device Lot Number: 0026808144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 70