MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER GEMINI¿; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	M0063301080
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 zero tip¿ stone retrieval basket was to be used for a procedure performed on an unknown date.According to the complainant, during unpacking, the packaging of the device was found to be difficult to open, which may have led to compromising the sterility of the device inside the pouch.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
An empty pouch was returned for analysis.A visual evaluation revealed that the returned pouch was completely opened and there were no residues of any sticky substance found.No other anomalies were noted.The complaint was not confirmed.The reported issue of "product not sterile" could not be functionally/visually verified since the package was already opened and no residues of any sticky substance were found on the pouch.The device was not returned.Additionally the reported issue of "package difficult to open" could not be confirmed since the pouch was already opened.Inspection indicates that the pouch met the appropriate quality inspection and manufacturing specification.Therefore, the most probable root cause is "design: product enhancement", since the device met the designed specification however a modification would improve performance, function or appearance of the product.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.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a zero tip stone retrieval basket was to be used for a procedure performed on an unknown date.According to the complainant, during unpacking, the packaging of the device was found to be difficult to open, which may have led to compromising the sterility of the device inside the pouch.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: GEMINI¿
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7607960
• Report Number: 3005099803-2018-01989
• Device Sequence Number: 16550082
• Product Code: FFL
• UDI-Device Identifier: 08714729087410
• UDI-Public: 08714729087410
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: 03/05/2021
• Device Model Number: M0063301080
• Device Catalogue Number: 330-108
• Device Lot Number: 21821892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 05/25/2018
• Supplement Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1