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

Model Number G50001

Device Problem Material Perforation (2205)

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

Event Date 11/26/2022

Event Type  malfunction  

Event Description

As reported, during a left tibial angioplasty, another manufacturer's wire guide perforated a cxi support catheter 2-3 cm from the distal tip.Access was gained in the femoral artery.The patient's anatomy was calcified.The catheter and wire were removed from the patient after the perforation was noted.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

Initial reporter name and address: phone: (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

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

Manufacturer Narrative

Summary of event: as reported, during a left tibial angioplasty, another manufacturer's wire guide perforated a cxi support catheter 2-3 cm from the distal tip.Access was gained in the femoral artery.The patient's anatomy was calcified.The catheter and wire were removed from the patient after the perforation was noted.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), quality control procedures, and a visual examination were conducted during the investigation.The complainant returned one cxi-2.6-18-150-p-ns-0 to cook for investigation.Physical examination of the returned device found that there was a kink at 67.9cm and a second kink/bend 67.2cm from the strain relief respectively.There was a flattened/compressed section about 8cm from the distal tip which was approximately 2cm in length.The 0.018" wire guide would not go through the kinked/compressed area.The reported failure was that the 0.014¿ guide wire perforated through the side of cxi catheter, however, no holes were noted in the sheath material.The catheter was submerged in water, and a syringe was attached to the hub and filled with air.When air was pushed through the catheter, no bubbles were noted.An 0.014" wire guide was able to pass through the full length of the device only feeling slight resistance at the kinked/bent and compressed areas.No holes were noted in the catheter material anywhere.After a discussion with the tubing supplier, it was concluded that a small puncture in the catheter material could occur without a leakage under a low pressure leak test.The product ifu provides the following information to the user related to the reported failure mode: precautions: ¿the catheter should not be advanced through and area of resistance unless the source of the resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ a review of the device history record for the reported lot found no relevant non-conformances.A database search for complaints on the reported lot found no additional lot related complaints from the field.A catheter component lot associated with the complaint lot records a relevant non-conformance on (b)(4) devices, however, all nonconforming product was scrapped.This component lot was used in three other final lots.A database search for complaints on these lots found no additional complaints reported.Although there are non-conformances relevant to the reported failure mode, all non-conforming product was scrapped, and there are 100% inspections to capture this non-conformance.Adequate inspection activities have been established, and there are no other lot related complaints that have been received from the field.At this time, cook concluded that no non-conforming product from this lot exists in house or in the field.A review of relevant manufacturing and quality control documents were conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the dmr, dhr, ifu, and investigation of the complaint photo and video provided, suggests that there is evidence the device was manufactured to specification.The complaint was confirmed based on customer testimony, provided photos and video, and returned device evaluation.Cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.It is possible that the calcified anatomy could have kinked the catheter and caused the wire puncture, but the perforation was unable to be verified in device examination.The risk analysis for this failure mode was reviewed and no additional escalation is 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.

• 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: 15999427
• MDR Text Key: 308262280
• Report Number: 1820334-2022-01862
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002500013
• UDI-Public: (01)00827002500013(17)240505(10)13941088
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G50001
• Device Catalogue Number: CXI-2.6-18-150-P-NS-0
• Device Lot Number: 13941088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2021
• 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
• Treatment: TERUMO 0.014" WIRE GUIDE
• Patient Age: 70 YR
• Patient Sex: Male