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

Model Number G18376

Device Problems Fracture (1260); Material Separation (1562); Stretched (1601); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, during a lower leg case intended to restore blood flow, a cxi support catheter was reportedly "defective".Access was obtained in the femoral artery.A wire was unable to threaded into the hub of the device, so the catheter was removed.An unknown micropuncture device and sheath were used during the procedure.Another device was used to continue the procedure.A section of the device did not remain inside the patients 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.Upon return and initial evaluation of the device, the hub was noted to be separated and the catheter shaft was elongated.Catheter material was observed in the hub.

Manufacturer Narrative

Description of event: as reported, during a lower leg case intended to restore blood flow, a cxi support catheter was reportedly "defective".Access was obtained in the femoral artery.A wire was unable to threaded into the hub of the device, so the catheter was removed.An unknown micropuncture device and sheath were used during the procedure.Another device 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.Upon return and initial evaluation of the device, the hub was noted to be separated and the catheter shaft was elongated.Catheter material was observed in the hub.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, documentation, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.One used cxi support catheter was received.The hub and strain relief were separated from the catheter.The catheter shaft was elongated.A kink was found at 78.4cm from the proximal end.Catheter material was observed in the hub.A review of the device history record found multiple potentially related non-conformances related to the reported failure mode, all of which were identified and scrapped.A review of complaint history records shows no other complaints associated with the complaint device lot.From the information provided upon review of the dmr and dhr, cook concluded that the device was manufactured to specification, and that there are no nonconforming devices in house or out in the field.The instructions for use (ifu) provides the following precautions related to the reported failure mode: ¿- this product is intended for use by physicians trained and experienced in small vessel access and interventional procedures.Standard techniques for placement of percutaneous catheters should be employed.- catheter manipulation should only occur under fluoroscopy.- the catheter should not be advanced into a vessel having a reference vessel diameter smaller than the catheter outer diameter.- the catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate steps are taken to reduce or remove the obstruction.¿ a review of relevant manufacturing documents was conducted.It was concluded that there are adequate controls in place to mitigate the risk of this failure mode.With current information, a definitive cause for this complaint could not be determined.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: CXI SUPPORT CATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11337124
• MDR Text Key: 234274358
• Report Number: 1820334-2021-00345
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002183766
• UDI-Public: (01)00827002183766(17)221120(10)10162942
• Combination Product (y/n): N
• PMA/PMN Number: K122796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2022
• Device Model Number: G18376
• Device Catalogue Number: CXI-2.3-14-150-ANG
• Device Lot Number: 10162942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1