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

Model Number G51581

Device Problem Material Perforation (2205)

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

Event Date 06/20/2023

Event Type  malfunction  

Event Description

As reported, during a procedure involving angioplasty of the left superficial femoral artery, a crosscath support catheter was perforated by an unspecified 0.038 or 0.035-inch, 260-centimeter coons wire guide.The catheter was inserted into the right femoral artery, and the user was reportedly advancing the catheter far enough over a tight bifurcation to be able to place a sheath.Upon advancing the wire guide, it "poked" through the catheter.The anatomy was both tortuous and calcified, and the procedure was unable to be completed due to the patient's difficult anatomy.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

E3: occupation: lab manager.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.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

Additional information was received 29aug2023.An unspecified rim catheter and cook 180-centimeter hiwire were initially used as the physician was attempting to go up-and-over the tight iliac bifurcation.When the rim catheter would not track any further, the physician used the complaint catheter to advance the wire enough to obtain up-and-over access with a sheath.The hiwire was removed and a 0.035-inch, 260-centimeter cook coons wire was advanced through the catheter as a more supportive wire; however, the wire was difficult to advance and exited the catheter at the bifurcation.Everything was removed, and there was no harm to the patient.

Manufacturer Narrative

Summary of event: as reported, during a procedure involving angioplasty of the left superficial femoral artery, a crosscath support catheter was perforated by an unspecified 0.038 or 0.035-inch, 260-centimeter coons wire guide.The catheter was inserted into the right femoral artery, and the user was reportedly advancing the catheter far enough over a tight bifurcation to be able to place a sheath.Upon advancing the wire guide, it "poked" through the catheter.The anatomy was both tortuous and calcified, and the procedure was unable to be completed due to the patient's difficult anatomy.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.Additional information was received 29aug2023.An unspecified rim catheter and cook 180-centimeter hiwire were initially used as the physician was attempting to go up-and-over the tight iliac bifurcation.When the rim catheter would not track any further, the physician used the complaint catheter to advance the wire enough to obtain up-and-over access with a sheath.The hiwire was removed and a 0.035-inch, 260-centimeter cook coons wire was advanced through the catheter as a more supportive wire; however, the wire was difficult to advance and exited the catheter at the bifurcation.Everything was removed, and there was no harm to the patient.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.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 ¿under fluoroscopic guidance, carefully advance the catheter to the desired location, making sure that the wire guide tip extends beyond the catheter tip at all times.¿ the information provided upon review of the dmr, dhr, and ifu 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 procedural issues contributed to this event.The bifurcation angle was reportedly tight, and the procedure could not be completed due to the patient¿s difficult anatomy.It is possible that the difficult anatomy contributed to difficult advancement of the wire guide, causing the wire to puncture 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

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

• 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: 17226780
• MDR Text Key: 318325515
• Report Number: 1820334-2023-00848
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002515819
• UDI-Public: (01)00827002515819(17)251107(10)15055984
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G51581
• Device Catalogue Number: CXC4.8-3.7-35-135-P-NS-0
• Device Lot Number: 15055984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• 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: .038 260 COONS WIRE.; COOK 180CM HIWIRE.; COOK COONS 0.035" 260CM WIRE.; RIM CATHETER.