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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION GRASPIT DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063204010
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Perforation (2001)
Event Date 02/25/2020
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to provide the device lot number; therefore, the lot expiration and device manufacture dates are unknown. (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a graspit nitinol stone retrieval forceps was used in the ureter during a lithotripsy procedure for removal of renal stones performed on (b)(6) 2020. According to the complainant, when trying to remove a lasered stone during the procedure the forceps broke at the tip were the forceps open. The fractured forceps was removed from the patient with another grasping forceps. However, the ureter was punctured from multiple attempts to remove the broken forceps. An attempt to insert a nephrostomy failed, and bilateral retroperitoneal drains were inserted instead. Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
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Brand NameGRASPIT
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key9865234
MDR Text Key184457600
Report Number3005099803-2020-01144
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM0063204010
Device Catalogue Number320-401
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/23/2020 Patient Sequence Number: 1
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