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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ESCAPE¿ DISLODGER, STONE, BASKET, URETERAL, METAL

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BOSTON SCIENTIFIC - SPENCER ESCAPE¿ DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063902010
Device Problem Device Packaging Compromised (2916)
Patient Problem No Patient Involvement (2645)
Event Date 05/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon 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 Description
It was reported to boston scientific corporation that an escape basket was to be used for an ureteroscopia flexible procedure to be performed on (b)(6) 2018. According to the complainant, during unpacking, the basket fell off. It was reported that the basket was wrapped with secondary packaging of cellophane from the factory. The sterilized packaging was found to be not sealed. There was no patient complications reported as a result of this event. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.
 
Manufacturer Narrative
An escape basket was returned for analysis. A visual evaluation of the device found that the basket was properly packaged inside the tray without any damages noted; however, the pouch was received open and it does not have any marks of the seal on its surface (tyvek or clear plastic side. ) the length and width of the returned pouch were measured and found to be within specification. The complaint was confirmed. Based on the available/gathered information and the inspection performed of the returned product, manufacturing execution error was selected as the most probable cause for this event, since the manufacturing process was not executed as validated/as designed. An investigation has been initiated 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. A search of the complaint database revealed that no other complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that an escape basket was to be used for an ureteroscopia flexible procedure to be performed on (b)(6) 2018. According to the complainant, during unpacking, the basket fell off. It was reported that the basket was wrapped with secondary packaging of cellophane from the factory. The sterilized packaging was found to be not sealed. There was no patient complications reported as a result of this event. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted. Additional information received as of july 16, 2018. The anatomy location was reported to be in the ureter.
 
Event Description
It was reported to boston scientific corporation that an escape basket was to be used for an ureteroscopia flexible procedure to be performed on (b)(6) 2018. According to the complainant, during unpacking, the basket fell off. It was reported that the basket was wrapped with secondary packaging of cellophane from the factory. The sterilized packaging was found to be not sealed. There was no patient complications reported as a result of this event. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted. Additional information received as of july 16, 2018: the anatomy location was reported to be in the ureter.
 
Manufacturer Narrative
Additional information: complainant name, complainant address, complainant city.
 
Event Description
It was reported to boston scientific corporation that an escape basket was to be used for an ureteroscopia flexible procedure to be performed on (b)(6) 2018. According to the complainant, during unpacking, the basket fell off. It was reported that the basket was wrapped with secondary packaging of cellophane from the factory. The sterilized packaging was found to be not sealed. There was no patient complications reported as a result of this event. Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted. Additional information received as of july 16, 2018: the anatomy location was reported to be in the ureter.
 
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Brand NameESCAPE¿
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
MDR Report Key7665058
MDR Text Key113284431
Report Number3005099803-2018-02165
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 06/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/29/2021
Device Model NumberM0063902010
Device Catalogue Number390-201
Device Lot Number21675884
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2018
Is This a Reprocessed and Reused Single-Use Device? No

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