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

Model Number	M0063901020
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).(b)(4).Visual analysis of the returned device found the sheath torn at proximal and distal section and kinked in several locations.One section of the sheath is still on the device, but the rest of the sheath was removed.The basket assembly was detached from the device and it was not returned for analysis.The device showed excessive manipulation, as it was severely damaged.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Handling and manipulation of the device during its use can lead to the kinking of the sheath in several locations; also interaction with the scope could have contributed with the encountered damages.Once the sheath is kinked at the distal end, this condition would cause friction between the sheath and the inner wire during the handle actuation at kinked areas, and continued attempts to open/close the basket or too much force applied to the handle can result in the tearing of the sheath and basket assembly detachment.The directions for use states "precaution: kinks in the sheath will hinder the mechanical operation of the basket." during its manufacturing process the product is inspected for functionality and integrity, however there is no control in how the units are handled during the procedure.Based on the information available and the analysis performed, the most likely root cause for the complaint is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip retrieval basket was used in a procedure performed on an unknown date.According to the complainant, the device was unable to open and close.The procedure completed with the another zero tip basket.There were no patient complications as a result of this event.Investigation results revealed that the sheath torn at distal end and basket detached; therefore, this is now an mdr reportable 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: 8903146
• Report Number: 3005099803-2019-04061
• Device Sequence Number: 18888980
• Product Code: FFL
• UDI-Device Identifier: 08714729342014
• UDI-Public: 08714729342014
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/16/2019

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 Model Number: M0063901020
• Device Catalogue Number: 390-102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/16/2019
• Patient Sequence Number: 1