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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ESCAPE; DISLODGER, STONE, BASKET, URETERAL, METAL
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BOSTON SCIENTIFIC CORPORATION ESCAPE; DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063902010
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that an escape basket was unpacked on an unknown date.During unpacking, the packaging of the basket was noted to be ripped on the side and the sterility was compromised.There was no patient or procedure involved.
 
Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: device code a020504 captures the reportable event of packaging ripped on the side.Block h10: the returned escape basket was analyzed, and a visual evaluation noted that the pouch was torn in one of the sides.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 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.
 
Event Description
It was reported to boston scientific corporation that an escape basket was unpacked on an unknown date.During unpacking, the packaging of the basket was noted to be ripped on the side and the sterility was compromised.There was no patient or procedure involved.
 
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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 Key12615247
MDR Text Key275890158
Report Number3005099803-2021-05262
Device Sequence Number1
Product Code FFL
UDI-Device Identifier08714729121299
UDI-Public08714729121299
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/10/2021
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
Device Operator Health Professional
Device Expiration Date06/23/2024
Device Model NumberM0063902010
Device Catalogue Number390-201
Device Lot Number0027550841
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/20/2021
Initial Date FDA Received10/12/2021
Supplement Dates Manufacturer Received10/19/2021
Supplement Dates FDA Received11/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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