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 Problem Foreign Body In Patient (2687)

Event Date 03/12/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a zero tip basket was used in the kidney and ureter during a cystoscopy and ureteroscopy procedure performed on (b)(6) 2021.During the procedure, when the zero tip was removed from the patient, the basket was noted to be missing.The physician went back in the ureter and kidney, and found the basket in the renal pelvis.The basket was attempted to be retrieved using another zero tip basket but was unsuccessful.The basket was left in situ and the patient was observed in recovery.The patient was transferred to another facility and is scheduled for another procedure to remove the detached basket in another hospital.The procedure name and date is unknown.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11959874
• MDR Text Key: 256230282
• Report Number: 3005099803-2021-02665
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729469643
• UDI-Public: 08714729469643
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2022
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 0026277957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention