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

Model Number M0063204010

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2020

Event Type  malfunction  

Manufacturer Narrative

(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 flexible ureterorenoscopy procedure performed on (b)(6) 2020.During the procedure, the forceps of the graspit broke off inside the flexible ureteroscope.Additionally, the sheath at the distal end snapped off.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.No patient complications were reported as a result of this event.

• Brand Name: GRASPIT
• 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: 11398697
• MDR Text Key: 234301776
• Report Number: 3005099803-2021-00769
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 08714729341758
• UDI-Public: 08714729341758
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2023
• Device Model Number: M0063204010
• Device Catalogue Number: 320-401
• Device Lot Number: 0025820220
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2020
• 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