MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BAGLEY; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063401220
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
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 bagley basket device was to be used in the kidney during a ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during preparation, the tip of the basket fully detached before inserting into the patient.The procedure was completed with another bagley basket.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a bagley basket device was to be used in the kidney during a ureteroscopy procedure performed on (b)(6) 2020.According to the complainant, during preparation, the tip of the basket fully detached before inserting into the patient.The procedure was completed with another bagley basket.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H10 block h6: device code 1069 captures the reportable event of tip of the basket detached.Block h10: visual inspection of the returned device found the basket was retracted when received.The sheath was detached in the proximal section near handle of the device.Additionally, the working length was found kinked at the proximal section near to the handle.Functional test was performed and found the device was not able to open/close the basket.When the handle was actuated.The basket was found not broken, which does not confirm the reported event.Based on all available information, the failures of sheath detached and working length kinked could have been generated due to manipulation of the device prior to use.It is likely that attempting to remove the unit from its packaging could have cause the kinks in the working length.Once it is kinked, it could have generated resistance during handle actuation.Continued attempts to actuate the handle or force applied to the handle could result in tearing of the sheath.Once the sheath is detached, the basket could become unable to open or close properly.The basket was found to not be broken however; as the reported problem could not be detected, the most probable root cause for the reported event could not be established.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

• Brand Name: BAGLEY
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10819556
• Report Number: 3005099803-2020-05150
• Device Sequence Number: 19308310
• Product Code: FFL
• UDI-Device Identifier: 08714729043485
• UDI-Public: 08714729043485
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 09/18/2023
• Device Model Number: M0063401220
• Device Catalogue Number: 340-122
• Device Lot Number: 0026038615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1