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

Model Number	M0063301080
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 gemini stone retrieval basket was to be used for a transurethral lithotripsy procedure performed on (b)(6) 2019.According to the complainant, the device was unpacked, and a long hair was found inside the sterile packaging.The procedure was completed with another gemini basket.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a gemini stone retrieval basket was to be used for a transurethral lithotripsy procedure performed on (b)(6) 2019.According to the complainant, the device was unpacked and a long hair was found inside the sterile packaging.The procedure was completed with another gemini basket.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code 2944 captures the reportable event of foreign material present in device.Block h10: visual analysis found the pouch was completely opened and the device was out of its pouch when received.A hair was observed inside the plastic tray.The device was received out of its pouch which indicates handling and manipulation of the device.Due to this reason, it is unknown if the hair found in the plastic tray occurred during the manufacturing process or if it occurred as a result of manipulation of the device after it left the manufacturing site.Manufacturing processes includes extensive inspections to ensure that devices meet specifications; however, there is no control how the devices are handled/manipulated in the field.Therefore, the most probable conclusion code for this complaint is "cause not established" since the investigation finding do not lead to a clear conclusion about the cause of the reported event.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 similar complaint trend review was performed and no other complaints have been reported for the specified lot.

• 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: 8798966
• Report Number: 3005099803-2019-03606
• Device Sequence Number: 3272837
• Product Code: FFL
• UDI-Device Identifier: 08714729087410
• UDI-Public: 08714729087410
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 02/28/2022
• Device Model Number: M0063301080
• Device Catalogue Number: 330-108
• Device Lot Number: 0023420953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1