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

Model Number	M0063301040
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	04/11/2018
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 basket was to be used for a procedure on (b)(6) 2018.According to the complainant, during unpacking, a hair was found in the packaging.There were no serious injury or adverse patient effects reported as a result of this event.Attempts to obtain further information have been unsuccessful to date, should any relevant information become available, a supplemental report will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a gemini basket was to be used for a procedure on (b)(6) 2018.According to the complainant, during unpacking, a hair was found in the packaging.There were no serious injury or adverse patient effects reported as a result of this event.Attempts to obtain further information have been unsuccessful to date, should any relevant information become available, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: device problem code 2944 captures the reported event of foreign matter in device packaging.H10: investigation results: an 11mm gemini device was returned for analysis.It was received closed/sealed and packaged inside its original pouch.A visual analysis of the returned device revealed that the sealed section of the pouch was in good condition and no damages were noted, however, a hair was found inside the pouch.It was concluded based on the information available and the analysis performed to the returned device that the investigation conclusion code for this complaint will be documented as manufacturing deficiency.There is an investigation opened to address this issue.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.

• 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: 7903875
• Report Number: 3005099803-2018-60568
• Device Sequence Number: 168447
• Product Code: FFL
• UDI-Device Identifier: 08714729087397
• UDI-Public: 08714729087397
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 06/25/2020
• Device Model Number: M0063301040
• Device Catalogue Number: 62335
• Device Lot Number: 0020813427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1