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

Model Number	M0063301100
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 or Problem Description
It was reported to boston scientific corporation that a gemini retrieval basket was unpacked on (b)(6) 2019.According to the complainant, when unpacking the product from the brown shipping box, the seal on one of the gemini basket packaging was found to be broken and the sterility of the device was compromised.The device was not used on a patient or procedure.
Additional Manufacturer Narrative
Device code 1444 captures the reportable event of packaging seal compromised.Visual inspection of the returned device found that the package (pouch) wrinkled in some areas and torn, this could have compromised the sterility of the device.As per complaint information, the issue occurred during unpacking, 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 handle or manipulated in the field.Based on all available information, 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) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a gemini retrieval basket was unpacked on (b)(6) 2019.According to the complainant, when unpacking the product from the brown shipping box, the seal on one of the gemini basket packaging was found to be broken and the sterility of the device was compromised.The device was not used on a patient or procedure.

• Brand Name: GEMINI
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8921095
• Report Number: 3005099803-2019-04211
• Device Sequence Number: 16748410
• Product Code: FFL
• UDI-Device Identifier: 08714729087427
• UDI-Public: 08714729087427
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2022
• Device Model Number: M0063301100
• Device Catalogue Number: 330-110
• Device Lot Number: 0023843866
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1