MAUDE Adverse Event Report: COOK INC MIRA-FLEX MICROCATHETER; KRA CATHETER, CONTINUOUS FLUSH

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a male patient required placement of a mira-flex microcatheter for a liver transarterial chemoembolization procedure.During the procedure, the operator noticed "the tip of the microcatheter was detached" when they pushed the chemotherapeutic drug through the needle.The device was replaced with a similar device to finish the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
D11- concomitant medical products: terumo 5f hepatic artery catheter.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Additional methods code: analysis of data provided by user/third party (4112).D10- product received on: 28oct2019.Investigation- evaluation: a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, dimensional verification, supplier investigation, as well as a visual inspection, were conducted during the investigation.One catheter was returned in a used and damaged condition.Biomatter was observed throughout the device.The catheter hub and strain relief were detached from the catheter tubing.The proximal end of the catheter tubing does not appear damaged.No tubing material was left within the catheter hub, or under the strain relief.The catheter was returned within a 5.0fr terumo catheter.The miraflex catheter could not be removed from inside the terumo catheter without resistance.76.5cm of the miraflex catheter tubing, without the hub, was noted to be exiting the proximal end of the terumo catheter.The miraflex catheter tubing was removed from the terumo catheter and appears undamaged.Biomatter was observed on the distal end of the miraflex after removal.Additionally a document based investigation evaluation was performed.Investigation did not identify gaps in the quality control process.The device history record of the complaint lot and related subassembly lots was reviewed to and revealed no related nonconformances.There is one additional complaint on the complaint lot.The additional complaint is on the same device, for the failure of the miraflex catheter becoming stuck within the terumo catheter during the same procedure.Based on the nonconformance and complaint history, there is no evidence of nonconforming material from this lot in house or in the field.The device is shipped with instruction for use (ifu) which states to flush the device with heparinized saline or sterile water to activate the hydrophilic coating prior to use.They also state that "the miraflex 18 microcatheter fits through any angiographic catheter that accepts a 0.035 inch wire guide." a supplier investigation was performed for the returned device.The supplier reviewed the dhr for the complaint lot and all the tensile strength values met the required specification.Ten (10) additional lots of the supplied component were reviewed and all the tensile strength values met the cook specification.It is possible that the medications injected through the catheter, procedural use, patient anatomy, or user error contributed to the failure, but these can not be confirmed.It is possible that biological matter created resistance in the catheter leading to hub separation.Based on the information provided, the examination of returned product, and the results of the investigation, it was concluded that a component failure without design or manufacturing issue caused or contributed to this event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Correction: this report is being sent to indicate the complaint event is not reportable.Upon further review, this event is not reportable.There is no information confirming reportable device malfunction or serious injury.Replacement of device to complete procedure is negligible harm and does not meet the criteria for a serious injury, per 21 cfr part 803.3.Additionally, 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 previously recorded incidences of serious injury due to microcatheter strain relief separation, 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.

• Brand Name: MIRA-FLEX MICROCATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 9209894
• Report Number: 1820334-2019-02650
• Device Sequence Number: 11500723
• Product Code: KRA
• UDI-Device Identifier: 10827002431154
• UDI-Public: (01)10827002431154(17)211211(10)9417305
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K052841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2021
• Device Model Number: N/A
• Device Catalogue Number: MF-2.5-18-135-15
• Device Lot Number: 9417305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 10/29/2019; 12/19/2019; 03/21/2022
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/12/2019; 01/02/2020; 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 55 KG