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

Model Number M0063901050

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2020

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).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a zero tip basket was unpacked on an unknown date.According to the complainant, a slit was found on the package when it was taken out from the shipping box and the sterility was compromised.There was no patient or procedure involved.

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 h2 : additional information: e1 (initial reporter first name, last name, phone), e3 (occupation) block h6: device code 2385 captures the reportable event of slit in packaging.Block h10: visual analysis found the device was returned in its original unopened pouch.The heat seal ran throughout entire length of the pouch without any breakage.The pouch was wrinkled is some areas.The back of the pouch had a cut that seemed to had been done with a sharp tool.Based on all available information, it is most likely that handling and manipulation of the device during transport/storage could have contributed to the encountered issue.Therefore, the most probable root cause is cause traced to transport/storage.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 Description

It was reported to boston scientific corporation that a zero tip basket was unpacked on an unknown date.According to the complainant, a slit was found on the package when it was taken out from the shipping box and the sterility was compromised.There was no patient or procedure involved.

• 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: 10192713
• MDR Text Key: 198932904
• Report Number: 3005099803-2020-02439
• 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: 07/21/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2021
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 0024726225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1