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

Model Number	M0063901010
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	10/18/2018
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip nitinol basket was prepped for use in a flexible ureteroscopy procedure to treat kidney stone, performed on (b)(6) 2018.According to the complainant, during unpacking and testing of the device, it was found that the basket cage was physically missing from the device.The seal of the package was reported to be intact before it was opened and there were no noted damages on the device packaging.The procedure was completed with another zero tip basket.There was no serious injury nor were there any adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).The complaint device was not returned by the customer.However, the customer provided a photo of the zero tip device.The photo was visually inspected and found the distal section of the working length of the device to be slightly bent.The section of the device where the basket goes placed is not present in the photo.The photo of the product provided by the user limited the proper evaluation of the device; the image does not show if the handle was actuated to an open position.It is unknown if the basket section is still inside of the sheath; or if it was totally detached or if only one of its sections presented any issue.The distal section of the pull wire (where the basket goes placed) needs to be evaluated visually/physically and under magnification in order to conclude the most probable cause and or if a damage in the unit could have contributed to the issue reported by the customer.Although the unit was not physically returned by the user; the photo provided an image of the device showing it in bent condition in the working length of the device, and this is a known failure that is normally caused due to an excess of force applied to a section of the product, usually if it is pulled or pushed strongly.Based on this analysis and the information available, it is concluded that the most probable conclusion code of this failure observed (working length bent) will be documented as "cause traced to component failure" since the failure was an expected or random component failure without any design or manufacturing issue.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.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip nitinol basket was prepped for use in a flexible ureteroscopy procedure to treat kidney stone, performed on (b)(6) 2018.According to the complainant, during unpacking and testing of the device, it was found that the basket cage was physically missing from the device.The seal of the package was reported to be intact before it was opened and there were no noted damages on the device packaging.The procedure was completed with another zero tip basket.There was no serious injury nor were there any adverse patient effects reported as a result of this event.

• 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: 8047118
• Report Number: 3005099803-2018-61278
• Device Sequence Number: 16441044
• Product Code: FFL
• UDI-Device Identifier: 08714729342007
• UDI-Public: 08714729342007
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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): 12/11/2018

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: 07/18/2021
• Device Model Number: M0063901010
• Device Catalogue Number: 390-101
• Device Lot Number: 0022402390
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1