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

Model Number G56551

Device Problems Material Separation (1562); Sharp Edges (4013)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter address: street: (b)(6).Concomitant medical products: hydro st, command wire, terumo gold wire-150 centimeter 0.018-inch (also separated).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 an interventional procedure of the tibial artery via retrograde pedal access, the tip of a cxi support catheter separated and remains in the patient.The vessels were reportedly highly calcified.Unknown angioplasty balloons were used during the procedure, as well as other manufacturers¿ wire guides.During the latter portion of the case, upon intervention using the complaint device and another manufacturer¿s 0.018-inch, 150-centimeter wire guide, the tip of the complaint device and the distal portion of the wire separated.The intervention was reportedly a last resort.The separated portions of both the catheter and wire guide were left in the patient and there are no plans to retrieve them.The patient is reportedly doing fine.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.

Event Description

Additional information was received 04may2021.A section of the device did not remain in the patient as originally reported.The device was removed from the patient during the procedure with no harm to the patient.A power injector was not used.Upon receipt of the complaint device, the catheter was not separated; however, the tip was jagged.

Manufacturer Narrative

Corrected information: the following sections were corrected based upon receipt of additional information 04may2021: h6 (annexes a.E.F).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, unchanged, or unavailable.Description of event: as reported, during an interventional procedure of the tibial artery via retrograde pedal access, the tip of a cxi support catheter separated and remains in the patient.The vessels were reportedly highly calcified.Unknown angioplasty balloons were used during the procedure, as well as other manufacturers¿ wire guides.During the latter portion of the case, upon intervention using the complaint device and another manufacturer¿s 0.018-inch, 150-centimeter wire guide, the tip of the complaint device and the distal portion of the wire separated.The intervention was reportedly a last resort.The separated portions of both the catheter and wire guide were left in the patient and there are no plans to retrieve them.The patient is reportedly doing fine.A section of the device did not remain in the patient as originally reported.The device was removed from the patient during the procedure with no harm to the patient.A power injector was not used.Upon receipt of the complaint device, the catheter was not separated; however, the tip was jagged.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, drawings, the instructions for use, manufacturing instructions, and quality control data.The complainant returned one, used catheter to cook for investigation.Physical examination of the returned device showed an overall length of 91.3cm and a tip length of 3mm.There was a kink located 19.5cm from the distal end and the end of the distal tip was jagged.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 steps are taken to reduce or remove the obstruction.¿ instructions for use ¿2.Activate hydrophilic coating by wetting the catheter with heparinized saline solution or sterile water.To ensure hydrophilic activation, wet the entire surface of the catheter.Note: the surface of the catheter may become dry if not used immediately after activation.Additional wetting with heparinized saline solution or sterile water will reactive the hydrophilic coating.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage had 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 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: CXI SUPPORT CATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11640444
• MDR Text Key: 261700242
• Report Number: 1820334-2021-01103
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002565517
• UDI-Public: (01)00827002565517(17)240205(10)13740296
• 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,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2024
• Device Model Number: G56551
• Device Catalogue Number: CXI-2.6-18-90-ANG
• Device Lot Number: 13740296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other