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

Model Number M0063902010

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Device code (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 medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an escape basket sterile pouch was found torn on (b)(6) 2021.During unpacking of the shipping box, one of escape basket sterile pouches was found to be torn.This event did not occur during a procedure, did not involve a patient, and occurred outside of an operating room.

Event Description

It was reported to boston scientific corporation that an escape basket sterile pouch was found torn on (b)(6) 2021.During unpacking of the shipping box, one of escape basket sterile pouches was found to be torn.This event did not occur during a procedure, did not involve a patient, and occurred outside of an operating room.

Manufacturer Narrative

Block h6: device code a020503 captures the reportable event of packaging seal compromised.Block h10: the returned escape basket was analyzed, and a visual evaluation noted that the was received with the connected luer and the basket was in an open position.No bents or kinks was noted on the sheath.The pouch was returned opened and a tear in the manufacturing seal 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 adverse 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 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 search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: ESCAPE
• Type of Device: 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: 12393814
• MDR Text Key: 269001077
• Report Number: 3005099803-2021-04532
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729121299
• UDI-Public: 08714729121299
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M0063902010
• Device Catalogue Number: 390-201
• Device Lot Number: 0027622901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1