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

Model Number G51577

Device Problems Break (1069); Peeled/Delaminated (1454)

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

Event Date 03/22/2022

Event Type  malfunction  

Event Description

As reported, a crosscath support catheter delaminated.The device was attempted to be advanced over a 0.018" wire guide but could not due to resistance.The catheter bunched, and a fragment separated from the catheter when removing from the wire.The device did not make patient contact.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

(b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.Corrected information: h6 (annex a) 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.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

Additional information received 07apr2022.Resistance was encountered while attempting to advance the catheter over a wire guide, and the catheter then accordioned.Per the reporter, the device was not advanced far enough to reach the patient.The user attempted to remove the catheter from the wire with force; the catheter elongated and was not smooth.Per the reporter, the catheter did not separate; however, upon return and initial evaluation of the device, the catheter had separated into two sections.

Event Description

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

Manufacturer Narrative

Event summary: the device was attempted to be advanced over a 0.018" wire guide but could not due to resistance.The catheter bunched, and a fragment separated from the catheter when removing from the wire.The device did not make patient contact.Resistance was encountered while attempting to advance the catheter over a wire guide, and the catheter then accordioned.Per the reporter, the device was not advanced far enough to reach the patient.The user attempted to remove the catheter from the wire with force; the catheter elongated and was not smooth.Per the reporter, the catheter did not separate; however, upon return and initial evaluation of the device, the catheter had separated into two sections.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.A visual inspection dimensional verification of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record (dhr), drawing, the instructions for use, manufacturing instructions, and quality control data.The complainant retuned one crosscath support catheter to cook for investigation.Physical examination of the returned device found that it was separated 140.3 cm from the strain relief and had evidence of stretching and elongation.The separated piece measured 44 cm in length and also exhibited stretch damage and was twisted.3 marker bands were visible.A review of the device history record (dhr) 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 related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: 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.The catheter should not be advanced through an area of resistance unless the source of resistance is identified by fluoroscopy and appropriate step are taken to reduce or remove the obstruction.Do not advance catheter without the wire extending out of the distal tip.This catheter should only be used by physicians qualified to perform percutaneous vascular interventions.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.Cook concluded that conditions related to the procedure were the cause of this incident.The customer stated that the user of the device was a trainee.The resistance encountered during removal likely caused the user to apply excessive force, leading to the separation of the catheter.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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.

• Brand Name: CROSSCATH 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 ; 8128294891
• MDR Report Key: 13967422
• MDR Text Key: 288504293
• Report Number: 1820334-2022-00502
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002515772
• UDI-Public: (01)00827002515772(17)240628(10)14054856
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G51577
• Device Catalogue Number: CXC3.4-2.2-18-150-P-NS-0
• Device Lot Number: 14054856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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: BOSTON SCIENTIFIC V18 WIRE