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

Model Number	M00547050
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 rx retrieval balloon was used in the distal bile duct during a stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device was inserted and resistance was felt near the tip of the scope which made the device unable to pass through.Continued attempts were made, but resistance was still felt.Reportedly, the device was removed from the patient and it was noticed that the device tip seemed to be lifted and had fine slip.The procedure was completed with a non-bsc device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used in the distal bile duct during a stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the device was inserted and resistance was felt near the tip of the scope which made the device unable to pass through.Continued attempts were made, but resistance was still felt.Reportedly, the device was removed from the patient and it was noticed that the device tip seemed to be lifted and had fine slip.The procedure was completed with a non-bsc device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 2981 captures the reportable issue of distal tip lifted.Block h10: 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.Block h11: the initial report submitted on this event on (b)(6) 2019 was submitted in error, as the event does not represent an mdr-reportable scenario.

• 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: 8700093
• Report Number: 3005099803-2019-02941
• Device Sequence Number: 2308765
• Product Code: FGE
• UDI-Device Identifier: 08714729790303
• UDI-Public: 08714729790303
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/11/2019

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: 02/05/2021
• Device Model Number: M00547050
• Device Catalogue Number: 4705
• Device Lot Number: 0023303179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1