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

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.

• Brand Name: GEMINI¿
• Type of Device: DISLODGER, 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 Key: 7607960
• MDR Text Key: 111306522
• Report Number: 3005099803-2018-01989
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729087410
• UDI-Public: 08714729087410
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1