MAUDE Adverse Event Report: C. R. BARD, INC. DIMENSION; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number 042313

Device Problem Material Fragmentation (1261)

Patient Problems Edema (1820); Hemorrhage/Bleeding (1888); Foreign Body In Patient (2687)

Event Date 12/14/2016

Event Type  malfunction  

Event Description

Patient for removal of calculus in right kidney.During procedure, a dimension basket was used to retrieve stone fragments.Due to considerable difficulty in distal right ureter in removing basket with gentle pressure, the basket was cut and it was left in place.A semi-rigid ureteroscope was inserted and gentle traction resulted in the basket fracture and it remained intraureteral.Fragments of basket were retrieved; tongs of basket remained.Various other maneuvers attempted to retrieve tongs of basket but were unsuccessful.Due to poor visualization from the ureteral manipulation and trauma and increased bleeding and edema, it was determined to be no longer safe and decision was made to abort procedure and place a stent.Fragments of stone and tongs of basket remained in patient's ureter.Stent to remain in place for passive dilation with plan to bring patient back to operating room in near future for retrieval of additional stone fragments and additional iatrogenic fragments of basket.Patient returned to operating room for cystoscopy, ureteroscopy with lithotripsy, basket stone extraction and insertion of ureteral right stent due to calculus of right kidney.Retained foreign body was successfully retrieved and removed from patient.Peer review conducted and concluded that it is unclear why basket broke during first procedure; basket sent back to manufacturer for further evaluation.

• Brand Name: DIMENSION
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 6278910
• MDR Text Key: 65791895
• Report Number: 6278910
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2020
• Device Model Number: 042313
• Device Catalogue Number: 042313
• Device Lot Number: BMZLM028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 72 YR
• Patient Weight: 79