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

Model Number M0063301060

Device Problems Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2019

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 gemini stone retrieval basket was unpacked on (b)(6) 2019. According to the complainant, during unpacking, two small particles were noticed in the sterile packaging of the gemini basket. There were no patient or procedure involved in this event.

Event Description

It was reported to boston scientific corporation that a gemini stone retrieval basket was unpacked on (b)(6) 2019. According to the complainant, during unpacking, two small particles were noticed in the sterile packaging of the gemini basket. There were no patient or procedure involved in this event.

Manufacturer Narrative

Block h6: device code 2969 captures the reportable event of foreign matter in packaging. Block h10: 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. Block h11: correction: h6, h10.

• Brand Name: GEMINI
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9554072
• MDR Text Key: 189888605
• Report Number: 3005099803-2019-06401
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729087403
• UDI-Public: 08714729087403
• 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,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/08/2022
• Device Model Number: M0063301060
• Device Catalogue Number: 330-106
• Device Lot Number: 0024074731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No