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

Model Number N/A

Device Problem Material Separation (1562)

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

Event Date 11/08/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: unknown.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported a male patient required placement of a cantata duo 2.8 superselective microcatheter for a splenic embolization procedure.After the coils were placed, the operator noted that the catheter broke inside of the patient, about 10cm from the distal end.The operator retrieved the separated portion with a snare.The procedure was completed successfully.No other adverse effects were reported for this incident.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5, d11 this report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Preliminary examination of the device returned 30nov2020 showed a kink/twist at the distal end of the catheter, but no evidence of separation.A small piece of metal/coiling that was snared from the patient as well as the competitor's snare were returned, however the metal is not a portion of the catheter.

Manufacturer Narrative

Correction: this report is being sent to indicate the complaint event is not reportable.Upon further investigation and discussion with the customer, this event is not reportable.It was determined that the only failure of the catheter was that it was twisted/bent.An embolization coil was snared from the patient due to it being mistaken as a portion of the catheter, however no issue with the catheter necessitated "medical or surgical intervention to preclude permanent impairment of a body structure or permanent damage to a body stricture." a review of risk documentation does not indicate that this event is likely to cause serious injury if it were to reoccur.As there are no recorded incidences of serious injury due to the complaint event, and it is not likely that serious injury would result if the event were to recur, per 21cfr part 803.50 the complaint event is considered not reportable.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: CANTATA DUO 2.8 SUPERSELECTIVE MICROCATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10825513
• MDR Text Key: 217947398
• Report Number: 1820334-2020-02075
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10827002238050
• UDI-Public: (01)10827002238050(17)220204(10)10317553
• Combination Product (y/n): N
• PMA/PMN Number: K101450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2022
• Device Model Number: N/A
• Device Catalogue Number: MCS-2.8-NT2-135-15-HP
• Device Lot Number: 10317553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK EMBOLIZATION COILS
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 23 YR