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

Model Number G52545

Device Problems Material Frayed (1262); Failure to Advance (2524)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

Description of event: as reported, during an evt a cxi support catheter stopped advance and was removed when it was found to be frayed.A contralateral approach was gained from the left femoral artery to treat a lesion in the anterior tibial artery.The below-knee region, including the sfa, was severely calcified.The cxi catheter was used to support the wire guide, but the calcification was severe and the catheter stopped advancing around the popliteal artery.The user then removed to the cxi and found the tip was frayed.The user than switched from a 0.035 system to a 0.018 system instead.A poba was then performed to the below-knee region and the procedure was completed.Investigation:evaluation: a document based investigation was performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.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.A database search revealed 1 other complaint, (b)(4), from lot 13262039 has been reported for device shaft kinked during use.Cook concluded that patient anatomy contributed to the failure mode, as severe calcification was reported.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 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.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and 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 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 patient anatomy contributed to this incident as severe calcification was reported and an alternative access site was required to complete the procedure.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.

Event Description

As reported, during an evt a cxi support catheter stopped advance and was removed when it was found to be frayed.A contralateral approach was gained from the left femoral artery to treat a lesion in the anterior tibial artery.The below-knee region, including the sfa, was severely calcified.The lesion was 90% occluded.The cxi catheter was used to support the wire guide, but the calcification was severe and the catheter stopped advancing around the popliteal artery.The user then removed to the cxi and found the tip was frayed.The user than switched from a 0.035 system to a 0.018 system instead.A poba was then performed to the below-knee region and the procedure was completed.The patient did not experience any adverse effects due to this occurrence.

• 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: 11627031
• MDR Text Key: 251414478
• Report Number: 1820334-2021-01085
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002525450
• UDI-Public: (01)00827002525450(17)230623(10)13262039
• Combination Product (y/n): N
• PMA/PMN Number: K160884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Model Number: G52545
• Device Catalogue Number: CXI-4.0-35-150-P-NS-DAV
• Device Lot Number: 13262039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• 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