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 07/11/2019

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 zero tip retrieval basket was unpacked on (b)(6) 2019.According to the complainant, when unpacking the product from the shipperbox, a tear was noticed in the device packaging.A photo from the customer confirms tears in the sterile device pouch.The device was not used on a patient or procedure.

Manufacturer Narrative

Block h6 device code 2385 captures the reportable event of hole in sterile device packaging.Block h10: visual inspection of the returned device found the pouch is completely sealed.The heat seal runs throughout the entire length of the pouch without any damage.The pouch is wrinkled in some areas and the back has a tear/hole which could have compromised the sterility of the device.It is most likely that the issue occurred due to handling and manipulation during transport or storage of the device.Manufacturing processes includes extensive inspections to ensure that all finished devices meet specifications; however, there is no control how the devices are handled or manipulated in the field.Based on the information available, the photos provided, and the analysis performed, the most probable root cause is "cause traced to transport/storage" since the problems traced to the inappropriate transport or storage of the device.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 retrieval basket was unpacked on (b)(6) 2019.According to the complainant, when unpacking the product from the shipperbox, a tear was noticed in the device packaging.A photo from the customer confirms tears in the sterile device pouch.The device was not used on a patient or procedure.

• 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: 8873359
• MDR Text Key: 153657212
• Report Number: 3005099803-2019-03990
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2021
• Device Model Number: M0063901050
• Device Catalogue Number: 390-105
• Device Lot Number: 0023893568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1