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

Model Number	M0063903010
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code a1802 captures the reportable event of presence of foreign matter in the sterile packaging.
Event or Problem Description
It was reported to boston scientific corporation that an opti-flex basket sterile pouch was found with a foreign matter on (b)(6) 2023.During preparation, it was observed that there was a debris in the sterile packaging of an opti-flex 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 an opti-flex basket sterile pouch was found with a foreign matter on april 24, 2023.During preparation, it was observed that there was a debris in the sterile packaging of an opti-flex basket.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a1802 captures the reportable event of presence of foreign matter in the sterile packaging.A picture provided by the customer shows that a foreign material was observed in the package.The returned trapezoid rx basket was analyzed, and a visual inspection observed that that the package only the pouch was received, the plastic tray was not returned with the device for analysis.No foreign material was observed in the pouch or device.The device did not have any visual issue/damage.The reported event of packaging foreign matter was confirmed per media inspection.A review of the manufacturing documentation for this reveled that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.Based on all available information, no foreign material was found in the returned device.However, the failure reported by the customer was confirmed based on a provided photo.According to the external support form (goi 90554509, ver.An), the product will be inspected, and any similar defects will be addressed according to the specified procedure.The information in the device history record (dhr) does not indicate any issues related to the reported defect.Since the package was already opened, it is not possible to determine the exact cause of the failure.Therefore, the most probable root cause is cause not established.

• Brand Name: OPTIFLEX
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16918322
• Report Number: 3005099803-2023-02562
• Device Sequence Number: 20513322
• Product Code: FFL
• UDI-Device Identifier: 08714729772859
• UDI-Public: 08714729772859
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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: 01/11/2025
• Device Model Number: M0063903010
• Device Catalogue Number: 390-301
• Device Lot Number: 0030837480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown