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

Model Number M0063901050

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a zero tip stone retrieval basket was used in a procedure performed on (b)(6) 2020.According to the complainant, during laser surgery, while trying to remove a 1.9 mm stone, the basket detached into the patient's ureter.The detached basket was retrieved using a piranha forceps and the procedure was continued and completed as planned.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: device code a0501 captures the reportable event of basket detached.Block h10: the complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a zero tip basket was used in a procedure performed on (b)(6) 2020.According to the complainant, during laser surgery, while trying to remove a 1.9 mm stone, the basket detached into the patient's ureter.The detached basket was retrieved using a piranha forceps and the procedure was continued as planned.There were no patient complications as a result of this event.Additional information received on january 22, 2021: the zero tip basket was used in the ureter during a ureteroscopy procedure.The procedure was completed with another zero tip basket.

• 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: 11166003
• MDR Text Key: 226776501
• Report Number: 3005099803-2020-06760
• 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: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2021
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 0023699466
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention