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

Model Number G51580

Device Problem Material Perforation (2205)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a procedure involving an angiogram, atherectomy, angioplasty, and stent placement within the leg, a hole was discovered on a crosscath support catheter.Access was obtained in the right common femoral artery.A short sheath was used to guide an unknown wire contralaterally to the left superficial femoral artery (sfa).The complaint device was advanced over the wire to the cross the lesion in the sfa.After the lesion was crossed, the user removed the wire and attempted to flush the catheter with contrast; however the catheter was not able to be flushed.The user then advanced an unknown wire through the catheter, and the wire exited the catheter at the iliac through a small hole.The complaint device was removed, and another catheter was used to continue the procedure.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

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

Event Description

Additional information was received 16sep2021.The event occurred at the beginning of the procedure, as the user was targeting the lesion.The iliac artery was not tortuous or calcified.Fluids were infused only once with a syringe; a power injector was not used.The procedure was completed successfully.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during a procedure involving an angiogram, atherectomy, angioplasty, and stent placement within the leg, a hole was discovered on a crosscath support catheter.Access was obtained in the right common femoral artery.A short sheath was used to guide an unknown wire contralaterally to the left superficial femoral artery (sfa).The complaint device was advanced over the wire to the cross the lesion in the sfa.After the lesion was crossed, the user removed the wire and attempted to flush the catheter with contrast; however the catheter was not able to be flushed.The user then advanced an unknown wire through the catheter, and the wire exited the catheter at the iliac through a small hole.The complaint device was removed, and another catheter was used to continue the procedure.Additional information was received 16sep2021.The event occurred at the beginning of the procedure, as the user was targeting the lesion.The iliac artery was not tortuous or calcified.Fluids were infused only once with a syringe; a power injector was not used.The procedure was completed successfully.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.The complainant returned one used crosscath support catheter (cxc4.8-3.7-35-90-p-ns-0) to cook for investigation.A hole was noted at 64cm from the strain relief.The device could not be flushed.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions ¿the catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate step are taken to reduce or remove the obstruction,¿ how supplied ¿upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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

No new patient or event information to report.

• 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: 12294681
• MDR Text Key: 265621713
• Report Number: 1820334-2021-01945
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002515802
• UDI-Public: (01)00827002515802(17)240223(10)13776006
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2024
• Device Model Number: G51580
• Device Catalogue Number: CXC4.8-3.7-35-90-P-NS-0
• Device Lot Number: 13776006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• 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
• Treatment: AMPLATZ ES WIRE; CORDIS SHORT SHEATH
• Patient Age: 84 YR
• Patient Sex: Female