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

Model Number M0063901050

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

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2019

Event Type  malfunction  

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 Description

It was reported to boston scientific corporation that a zero tip basket stone retrieval basket was to be used in the kidney during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2019.According to the complainant, when the zero tip basket was inspected prior to the procedure, after opening and closing the basket once as a test, the sheath was found buckled and broken at the distal end.As a result, the basket failed to closed.Another zero tip basket was used to complete the procedure.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure is reported to be good.

Manufacturer Narrative

Device code 1069 captures the reportable event of sheath break at the distal end.Visual analysis of the returned device found the basket was opened when received.The sheath was found buckled and detached in the proximal section, and bent at the distal end.Additionally, the sheath was found retracted in the distal section due to the buckled sheath at the proximal section.The handle was actuated; however, the basket was unable to close completely.Based on all available information, the failures found are issues that could have been generated due to the manipulation of the device during unpacking/prepping/testing.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 basket stone retrieval basket was to be used in the kidney during a retrograde intrarenal surgery (rirs) procedure performed on (b)(6) 2019.According to the complainant, when the zero tip basket was inspected prior to the procedure, after opening and closing the basket once as a test, the sheath was found buckled and broken at the distal end.As a result, the basket failed to closed.Another zero tip basket was used to complete the procedure.No patient complications were reported as a result of this event.The patient's condition at the conclusion of the procedure is reported to be good.

• 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: 9224128
• MDR Text Key: 178741973
• Report Number: 3005099803-2019-05163
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: 08714729469643
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 0023959349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR