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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - SPENCER GEMINI¿ DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063301080
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
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 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.
 
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 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.
 
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Brand NameGEMINI¿
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer (Section G)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key7607960
MDR Text Key111306522
Report Number3005099803-2018-01989
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/05/2021
Device Model NumberM0063301080
Device Catalogue Number330-108
Device Lot Number21821892
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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