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

Model Number M0063901030

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

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 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
• 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: 12518909
• Report Number: 3005099803-2021-04988
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729342021
• UDI-Public: 08714729342021
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 51 YR