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

Model Number	M0063301060
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/28/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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.
Event or Problem 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.
Additional Manufacturer Narrative
Block h6: device code 2969 captures the reportable event of foreign matter in packaging.Block h10: visual inspection found the device was returned in its sealed pouch.The heat seal runs throughout the entire length of the pouch without any breakage.Two small particles were observed between tray and tray lid.These particles were checked with a tappi chart and both were found to be within the allowable size of loose particulate.Materials testing analysis and characterization (mtac) results of both particles indicate that foreign material appears red in color.It is hypothesized to be lower atomic number than the base material, and it is hypothesized to be composed of organic material.Since fourier transform infrared spectroscopy (ftir) and ramen did not reveal any protein and found the foreign material was spectrally similar to the base material, the foreign material is hypothesized to be burnt polymer resin.Additionally, blue foreign material observed in the submitted carton and the blue foam holder within the carton is spectrally similar to the blue foam holder.The investigation of the complaint device found that the reported foreign matter was within acceptable limits of loose particulate and can be traced back to the materials used in the manufacturing and packaging.Therefore, the most probable cause code is no problem detected.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.A similar complaint review was performed and found no other complaints for the reported lot number.

• 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: 9554072
• Report Number: 3005099803-2019-06401
• Device Sequence Number: 19321141
• Product Code: FFL
• UDI-Device Identifier: 08714729087403
• UDI-Public: 08714729087403
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2020

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: 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
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/06/2020; 04/02/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 01/08/2020; 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1