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

Model Number M0063905000

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and 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

It was reported to boston scientific corporation that a dakota basket device was to be used in a retrograde intrarenal surgery procedure on (b)(6) 2020.According to the complainant, during preparation, a slit was noticed on the packaging.Another dakota basket was used to complete the procedure.There were no patient complications as a result of this event.

Manufacturer Narrative

Block h6: device code 2385 captures the reportable event of slit in device packaging.Block h10: visual analysis found the device was returned in its original unopened pouch.The heat seal ran throughout the entire length of the pouch without any breakage.The pouch was found wrinkled in some areas.A cut was found on the back of the pouch that seemed to have been done with a sharp tool, which confirms the reported event.The customer had provided a photo of the device showing the damage as well.It is most likely that handling and manipulation of the device during transport and/or storage could have contributed to the encountered issue.Manipulation of the device can lead to damaging of the package during transport and/or storage.Therefore, the most probable root cause is cause traced to transport/storage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.

Event Description

It was reported to boston scientific corporation that a dakota basket device was to be used in a retrograde intrarenal surgery procedure on (b)(6) 2020.According to the complainant, during preparation, a slit was noticed on the packaging.Another dakota basket was used to complete the procedure.There were no patient complications as a result of this event.

• Brand Name: DAKOTA
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10379644
• MDR Text Key: 202043733
• Report Number: 3005099803-2020-03114
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729937364
• UDI-Public: 08714729937364
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2022
• Device Model Number: M0063905000
• Device Catalogue Number: 63057
• Device Lot Number: 0024546054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1