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

Model Number	M0063204010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Event or Problem 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.Additional information received on april 1, 2020.The patient was reported to be a child, and the patient's current condition was reported to be okay.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device problem code 2907 captures the reportable event of the forceps detached.Patient code 2001 captures the reportable event of perforation.Conclusion code 4316 is being used in lieu of an adequate conclusion code for "device not returned." block h10: 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.

• Brand Name: GRASPIT
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9865234
• Report Number: 3005099803-2020-01144
• Device Sequence Number: 16960952
• Product Code: FFL
• UDI-Device Identifier: 08714729341758
• UDI-Public: 08714729341758
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0063204010
• Device Catalogue Number: 320-401
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention