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

Model Number	M0063901010
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a zero tip basket was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the basket would not open to release the stone.The handle was disassembled in order to open the basket and release the stone.The procedure was completed with another zero tip basket.There were no serious injuries nor adverse patient effects as a result of this event.The patient was reported to be stable post procedure.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip basket was used in the ureter during a ureteroscopy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the basket would not open to release the stone.The handle was disassembled in order to open the basket and release the stone.The procedure was completed with another zero tip basket.There were no serious injuries nor adverse patient effects as a result of this event.The patient was reported to be stable post procedure.
Additional Manufacturer Narrative
(b)(4).Visual analysis found the zero tip device was returned completely disassembled.The components returned do not have any visual damage.The basket-wire assembly was not returned for analysis, therefore it could not be inspected in order to verify if there was any visual/functional issue that could have contributed with the complaint; consequently, confirming the reported complaint.As per complaint information the customer disassembled the device, therefore it is not considered as an issue of the device.Since the device returned completely disassembled, the customer allegation could no be visually/functionally verified and the components returned did not present any visual damage.Therefore, it was concluded that the investigation conclusion code of this event is "no problem detected" since the device complaint or problem cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.

• Brand Name: ZERO TIP
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7872849
• Report Number: 3005099803-2018-60416
• Device Sequence Number: 2217652
• Product Code: FFL
• UDI-Device Identifier: 08714729342007
• UDI-Public: 08714729342007
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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: 05/17/2021
• Device Model Number: M0063901010
• Device Catalogue Number: 63430
• Device Lot Number: 0022140475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1