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

Model Number G51574

Device Problem Material Perforation (2205)

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

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfg: 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.

Event Description

As reported, during an angioplasty procedure, an unspecified cto wire perforated a crosscath support catheter, making a hole in the device.The procedure was successfully completed with another catheter.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.

Manufacturer Narrative

Summary of event: as reported, during an angioplasty procedure, an unspecified cto wire perforated a crosscath support catheter, making a hole in the device.The procedure was successfully completed with another catheter.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), manufacturing instructions, 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.A hole was noted in the catheter approximately 5.5-millimeters from the distal tip.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.There are 100% inspection activities in place to identify this failure prior to distribution.The product ifu states "the catheter should not be advanced into an area of resistance unless source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction." the ifu also instructs "do not advance the catheter without the wire extending out of the distal tip.Only use wire guides of the recommended diameter and length." 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 a component failure unrelated to manufacturing or design deficiencies contributed to this incident.Although it is possible that the catheter could have been perforated by the wire if the tip of the wire did not extend beyond the tip of the catheter, it is unknown if this is the case in this instance.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

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

• Brand Name: CROSSCATH 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: 14702472
• MDR Text Key: 301567741
• Report Number: 1820334-2022-01069
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002515741
• UDI-Public: (01)00827002515741(17)241005(10)14254896
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G51574
• Device Catalogue Number: CXC3.0-1.9-14-150-P-NS-0
• Device Lot Number: 14254896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• 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