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

Model Number M0063901030

Device Problems Break (1069); Deformation Due to Compressive Stress (2889); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

Medwatch #: mw5090836.(b)(4).Visual inspection found the basket was closed when received.The sheath is bent, buckled, and detached in the distal section.Functional inspection found the basket could not be open due to the damages observed on the sheath.Based on all available information, the investigation concluded that the failures observed are issues that could have been generated due to handling or manipulation of the device during the procedure, leading to the reported failure.Therefore, the most probable root cause is adverse event related to procedure.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.

Event Description

It was reported to boston scientific corporation that a zero tip retrieval basket was used in a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the basket failed to open.There were no patient complications as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Investigation results revealed that the sheath is torn at distal end; therefore, this is now an mdr reportable event.

Event Description

It was reported to boston scientific corporation that a zero tip retrieval basket was used in a procedure performed on (b)(6), 2019.According to the complainant, during the procedure, the basket failed to open.There were no patient complications as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Investigation results revealed that the sheath is torn at distal end; therefore, this is now an mdr reportable event.Please see block h10 for full investigation details.

Manufacturer Narrative

Medwatch #: mw5090836.Block h6: device code 1069 captured the reportable investigation finding of sheath detached at distal section.However, upon reevaluation of the product investigation, it was discovered the sheath was not detached or torn.Therefore, this no longer constitutes a reportable event.Block h10: visual inspection found the basket was closed when received.The sheath is bent and buckled in the distal section.Functional inspection found the basket could not be open due to the damages observed on the sheath.Based on all available information, the investigation concluded that the failures observed are issues that could have been generated due to handling or manipulation of the device during the procedure, leading to the reported failure.Therefore, the most probable root cause is adverse event related to procedure.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: ZERO TIP
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9695141
• MDR Text Key: 190156752
• Report Number: 3005099803-2020-00360
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729342021
• UDI-Public: 08714729342021
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2020
• Device Model Number: M0063901030
• Device Catalogue Number: 390-103
• Device Lot Number: 0023724425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1