MAUDE Adverse Event Report: COOK INC CANTATA 2.8 SUPERSELECTIVE MICROCATHETER; KRA CATHETER, CONTINUOUS FLUSH

Model Number N/A

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

Patient Problems Blood Loss (2597); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).510k #: k101450.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

Patient status post partial nephrectomy with persistent post-operative bleeding.Underwent renal angiography and coiling.Upon removal of the catheter it was noted catheter tip was missing - 33 cm of the catheter broke off in the patient's kidney.An open laparotomy by the vascular surgeon and the use of a snare to remove the catheter were both unsuccessful.Due to excessive post operative bleeding after partial and inability to retrieve catheter tip, call was made to remove the affected kidney.Patient transferred to intensive care unit where they continued to have bleeding problems.The patient has required ventilatory support, continuous renal replacement therapy, and multiple blood products and clotting factors.They have returned to the operating room three times for reexploration, packing, packing removal, and closure.The user stated that the device malfunction had no connection with the patient losing the kidney; prior to this procedure, the patient reportedly had a partial nephrectomy, and the user facility was expecting the patient to eventually lose the entire kidney.According to the customer, no lot number or other manufacturing information was available for reporting purposes.Catheter packaging was discarded prior to knowledge of catheter fracture.

Manufacturer Narrative

Date of report: 05/07/2018 : report submitted to correct date of report for previous follow-up report.The event is currently under investigation.A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

Additional information: additional information received identified that per the last available information, the patient was doing ok.The complainant stated they would not be able to provide any further information.The event is currently under investigation.A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the complaint history, drawing, documentation, instructions for use (ifu), quality control, specifications and a visual inspection/dimensional verification of the returned device were conducted during the investigation.Clinical assessment: the mcs-2.8-nt-150-15-hp is used in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral and coronary use.There is no information regarding he storage or handling of the mcs-2.8-nt-150-15-hp.Per the ifu, ¿damage to the catheter may result from exposure to heat or steam.There is no information regarding any resistance noted during the procedure.Per the ifu, ¿if resistance is felt between the vessel and microcatheter and wire guide, verify the cause of resistance by fluoroscopy or remove the microcatheter and wire guide as a unit.Damage may occur to the microcatheter and/or wire guide.¿ there is no information regarding other devices used in this procedure.Per the ifu, ¿the cantata 2.8 and cantata 2.8 duo microcatheters fit through any angiographic catheter that accepts a 0.038 inch wire guide.¿ at this time, the clinical assessment cannot eliminate any possible causes for this event such as device handling, user technique, human anatomy, incompatible device, device failure, or manufacturing related causes.The visual inspection of the returned device confirmed that both ends of the catheter segment were necked down, preventing accurate measurement of the catheter inner diameter.However, the catheter outer diameter was measured to be 0.034¿, which meets the 0.037¿ maximum specification.As little information was provided regarding the procedure performed, the patient anatomy, or other products and equipment used, it is unclear if the cause of the event is related to the patient condition or procedural use.Similarly, because only a 1.5cm, damaged section of catheter was returned, and the lot number for the complaint device was not provided, it is unclear if the cause of the event could be related to product manufacturing.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.However, a complaint search revealed two similar complaints in a three-year time period preceding the investigation.However, the related complaint devices were from a lots that were not distributed to the reporting user facility of this complaint.A review of the device master record (dmr) was performed; the documents reviewed included material specifications, drawings, quality control instructions, and instructions for use.No gaps related to the tensile performance of the device were noted in the reviewed documents.Thus, established controls are in place to ensure that this product met its design requirements prior to distribution.Based on the established controls in the dmr, the force at break studies in the dhf, and the conforming outer diameter of the returned device, the complaint product is not believed to have been manufactured out of specification.Ifu also contains the following instruction in the ¿how supplied¿ section: ¿upon removal from the package, inspect the product to ensure no damage has occurred.¿ based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints and will notify the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.

• Brand Name: CANTATA 2.8 SUPERSELECTIVE MICROCATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7041398
• MDR Text Key: 92333217
• Report Number: 1820334-2017-01363
• 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: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MCS-2.8-NT-150-15-HP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 112