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

Model Number M0063901050

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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

Note: this event pertains to one of four zero tip baskets unpacked for the same procedure.It was reported to boston scientific corporation that a zero tip basket was unpacked for a procedure on an unknown date.According to the complainant, prior to the procedure, two devices were unpacked, and the customer noticed that there was a black dye seeping through the devices packaging.Two more packages were discovered to have black dye seeping through the packages.The customer did not use any of the four devices in the procedure.The procedure was completed with a fifth zero tip basket.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: device code 2944 captures the reportable event of foreign material.Block h10: visual inspection found the device was returned with the wire basket removed out of its original position; however, it did not present any visual damage or abnormalities.No foreign matter was found on the packaging.The investigation concluded that, due to the limited information provided by the complainant, a definitive root cause for the event could not be determined.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.A search of the complaint database revealed that no other complaints exist for the specified lot.

Event Description

Note: this event pertains to one of four zero tip baskets unpacked for the same procedure.It was reported to boston scientific corporation that a zero tip basket was unpacked for a procedure on an unknown date.According to the complainant, prior to the procedure, two devices were unpacked, and the customer noticed that there was a black dye seeping through the devices packaging.Two more packages were discovered to have black dye seeping through the packages.The customer did not use any of the four devices in the procedure.The procedure was completed with a fifth zero tip basket.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event 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
• MDR Report Key: 9683077
• MDR Text Key: 190154824
• Report Number: 3005099803-2020-00289
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 0024814049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1