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

Model Number G50003

Device Problem Material Perforation (2205)

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

Event Date 02/08/2023

Event Type  Injury  

Event Description

As reported, during a procedure involving angioplasty of the anterior tibial artery, a cxi support catheter was perforated by another manufacturer's wire guide.Upon opening the device, a subtle bend was noted at the tip of the catheter; however, retrograde access was obtained in the anterior tibial artery and the catheter was passed over the other manufacturer's 0.014-inch wire guide.Reportedly, the wire passed easily through the catheter, but perforated the catheter through a "tiny hole" and went past the catheter tip.The device was reportedly difficult to retrieve safely and therefore the device was retrieved through another puncture site.It is unknown what devices were used to retrieve the catheter.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested.

Manufacturer Narrative

Name and address - additional 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.

Manufacturer Narrative

Summary of event: as reported, during a procedure involving angioplasty of the anterior tibial artery, a cxi support catheter was perforated by another manufacturer's wire guide.Upon opening the device, a subtle bend was noted at the tip of the catheter; however, retrograde access was obtained in the anterior tibial artery and the catheter was passed over the other manufacturer's 0.014-inch wire guide.Reportedly, the wire passed easily through the catheter, but perforated the catheter through a "tiny hole" and went past the catheter tip.The device was reportedly difficult to retrieve safely and therefore the device was retrieved through another puncture site.It is unknown what devices were used to retrieve the catheter.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information was received 08may2023.The anatomy was not tortuous, and resistance was not encountered upon advancement of the wire guide or the cxi.The device was used in a conical lesion below-the-knee.An unspecified 6-french sheath was used during the procedure.The wire and catheter were both difficult to retrieve and were pulled together as a unit.The tip of the cxi did not separate.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 and functional test of the complaint device was also conducted.The complaint device was returned to cook for investigation.The catheter was kinked approximately 27.5-centimeters from the distal tip.A 0.018-inch wire would not pass through the kinked section.No holes or perforation were noted in the catheter, and no air bubbles were noted upon submersion of the device in water.However, after discussion with the raw tubing supplier, cook concluded that a small puncture in the catheter could occur without leakage at low pressures.A document-based investigation evaluation was performed.No related non-conformances were found on the final lot, and there have been no other reported complaints for this lot number or any final lot number using the same subassembly lots.Four relevant non-conformances were noted on subassembly lots; however, all affected product was scrapped and there are 100% inspections in place to capture the non-conformance.The product ifu states ¿the catheter should not be advanced through an area of resistance unless the source of the resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ 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.Although four relevant non-conformances were noted on a sub-assembly lots, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that non-conforming product exists 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 event.Although it is also possible that the patient¿s anatomy contributed to the event, the customer did not report any difficulties during advancement of the device.The patient reportedly had a rutherford classification of 5, which is defined as minor tissue loss defined by a nonhealing ulcer or focal gangrene.This means that the patient had critical limb ischemia from reduced arterial blood flow to the foot.It is likely that the arteries, including the anterior tibial artery (which is both where retrograde access was obtained and the target site for angioplasty), were significantly occluded, which may have led to difficult advancement and kinking of the catheter.Although a hole was not found in the catheter upon return of the device, it is possible that the 0.014¿ wire guide may have perforated the cxi at the point of the kink, and once the catheter was straightened, the hole could no longer be found.After discussions with the raw catheter tubing supplier, cook concluded that a small puncture in the catheter shaft could have occurred and that there would not be any leakage under low pressures.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 was received 08may2023.The anatomy was not tortuous, and resistance was not encountered upon advancement of the wire guide or the cxi.The device was used in a conical lesion below-the-knee.An unspecified 6-french sheath was used during the procedure.The wire and catheter were both difficult to retrieve and were pulled together as a unit.The tip of the cxi did not separate.

• 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: 16419109
• MDR Text Key: 310042001
• Report Number: 1820334-2023-00173
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002500037
• UDI-Public: (01)00827002500037(17)250913(10)14953324
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G50003
• Device Catalogue Number: CXI-2.6-18-150-P-NS-ANG
• Device Lot Number: 14953324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 05/08/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• 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: 0.014-INCH ABBOTT COMMAND WIRE; COOK MICROPUNCTURE SET
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male