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

Model Number	M0063901030
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported that a zero tip basket was used in the ureter during a ureteroscopic lithotripsy procedure performed on (b)(6) 2021.During the procedure, the zero tip basket was inserted into the ureteroscope working channel and a thread was found at the tip of the sheath.Photos provided by the customer confirmed the tip of the sheath was torn.The procedure was completed with another zero tip basket.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block e1: this event was reported by the nurse.The physician present for this case was: (b)(6).Block h6: device code a0414 captures the reportable event of sheath torn at the distal end.Block h10: the returned zero tip basket was analyzed, and a visual analysis found the basket was extended when received.The distal end of the sheath was found bent and a thread was observed.Functional inspection found the basket opens and closes normally.The photo submitted by the customer was investigated.The pictures show the distal end of the sheath was bent and a thread was observed.No other issues with the device were noted.The reported event was not confirmed.Based on all available information, it is possible that the operational factors, such as handling / manipulation, interaction with other device, anatomy of the patient, or excess of force applied could have caused the problem found and consequently affects the performance of the device.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 or Problem Description
It was reported that a zero tip basket was used in the ureter during a ureteroscopic lithotripsy procedure performed on (b)(6) 2021.During the procedure, the zero tip basket was inserted into the ureteroscope working channel and a thread was found at the tip of the sheath.Photos provided by the customer confirmed the tip of the sheath was torn.The procedure was completed with another zero tip basket.There were no patient complications as a result of this 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: 12518909
• Report Number: 3005099803-2021-04988
• Device Sequence Number: 4460060
• Product Code: FFL
• UDI-Device Identifier: 08714729342021
• UDI-Public: 08714729342021
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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 Expiration Date: 04/06/2024
• Device Model Number: M0063901030
• Device Catalogue Number: 390-103
• Device Lot Number: 0027100363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR