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

Model Number	M0063902010
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an escape basket was unpacked on (b)(6) 2021 for a ureteroscopy.During preparation, a hole was noticed in the packaging and the sterility of the device was compromised.Another escape basket was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
This event was reported by the materials manager.(b)(6).(b)(4).The device has been received for analysis.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an escape basket was unpacked on (b)(6) 2021 for a ureteroscopy.During preparation, a hole was noticed in the packaging and the sterility of the device was compromised.Another escape basket was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block e1: this event was reported by the materials manager.The physician present for this case was: (b)(6).Device code a020504 captures the reportable event of hole in the packaging.Block h10: the returned escape basket was analyzed, and a visual evaluation noted that the pouch was torn in one of the sides.The unit did not present issues due to was inside of the original pouch and the tray looks closed.No other issues was noted.Based on all available information, the most probable root cause is cause not established since the investigation findings do not lead to a clear conclusion about the cause of the reported event.There is no evidence of a manufacturing issue, design or user issue which could have caused the complaint.As per external support form it was concluded that the manufacturing process has enough controls to assure the product performance.Most likely procedural factors as handling of the device boxes prior to use, could have led to the reported event.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

• Brand Name: ESCAPE
• 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: 12779025
• Report Number: 3005099803-2021-05800
• Device Sequence Number: 14958759
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: 08714729121299
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: 07/23/2023
• Device Model Number: M0063902010
• Device Catalogue Number: 390-201
• Device Lot Number: 0025759741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• 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