MAUDE Adverse Event Report: COOK MEDICAL CANTATA 2.8 MICROCATHETER

Model Number UNAVAILABLE

Device Problems Break (1069); Fracture (1260); Material Fragmentation (1261)

Patient Problems Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)

Event Date 11/01/2017

Event Type  Injury  

Event Description

Pt status post partial nephrectomy with persistent post-operative bleeding.Underwent renal angiography and coiling.Upon removal of catheter, it was noted catheter tip was missing.Open laparotomy to remove catheter by vascular surgeon was unsuccessful.Due to excessive post operative bleeding after partial nephrectomy and inability to retrieve catheter tip, call was made to remove the affected kidney.Pt transferred to icu where he continued to have bleeding problems.He has required ventilatory support, crtt, and multiple blood products and clotting factors.He has returned to operating room times three for reexploration, packing, packing removal and closure.Catheter packaging was discarded in heavily soiled biohazardous waste prior to knowledge of catheter fracture.No lot number or other mfg info was available for reporting purposes.

• Brand Name: CANTATA 2.8 MICROCATHETER
• Type of Device: MICROCATHETER
• Manufacturer (Section D): COOK MEDICAL; bloomington IN
• MDR Report Key: 7037441
• MDR Text Key: 92491664
• Report Number: 7037441
• Device Sequence Number: 1
• Product Code: KRA
• 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: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNAVAILABLE
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2017
• Distributor Facility Aware Date: 11/03/2017
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 112