MAUDE Adverse Event Report: COOK INC CXI SUPPORT CATHETER; KRA CATHETER, CONTINUOUS FLUSH

Model Number G52542

Device Problem Material Perforation (2205)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

Customer name and address = (b)(6).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 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 Description

As reported, a cxi support catheter was used to deploy a nester embolization device, against the advice of a company representative.The coil became stuck in the cxi, and as an unspecified wire was used to push the coil out, the wire perforated the catheter, making a hole in the device that the wire came through.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

No additional information has been received since the last report was submitted.

Manufacturer Narrative

Summary of event: as reported, a cxi support catheter was used to deploy a nester embolization device, against the advice of a company representative.The coil became stuck in the cxi, and as an unspecified wire was used to push the coil out, the wire perforated the catheter, making a hole in the device that the wire came through.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The device was received with an unknown wire guide lodged inside.The catheter was twisted, and the wire exited the catheter shaft 82-centimeters from the hub.The distal end of the wire was twisted with off-set coils.There is no evidence from the device failure analysis that the complaint device was manufactured out of specification.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu states, ¿the cxi support catheter with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange and wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents.¿ the nester coil ifu explains: product recommendations: for.035¿ coil size diameter call for catheter type and sizes hnb®4.1-35, hnb®5.0-35, hnb®6.0-35, and scbr5.0-35.The information provided upon review of the dmr, dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that unintended user error contributed to this event.The cxi is not recommended for use with the nester coil, and the cxi that was used in this case was smaller than the catheter sizes recommended in the nester ifu.It is likely that the coil became stuck and attempts to manipulate the coil with the wire caused the wire to perforate the catheter.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 Description

Additional information regarding concomitant devices was received.

Manufacturer Narrative

H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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 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.

• Brand Name: CXI SUPPORT CATHETER
• Type of Device: 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: 14575151
• MDR Text Key: 301020394
• Report Number: 1820334-2022-00991
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002525429
• UDI-Public: (01)00827002525429(17)230213(10)10326720
• Combination Product (y/n): N
• PMA/PMN Number: K160884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2022

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
• Device Operator: Health Professional
• Device Model Number: G52542
• Device Catalogue Number: CXI-4.0-35-135-P-NS-0
• Device Lot Number: 10326720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 08/01/2022; 08/22/2022
• Supplement Dates FDA Received: 08/03/2022; 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2020
• 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
• Treatment: MWCE-35-6-6-NESTER LOT 14017684.