MAUDE Adverse Event Report: COOK INC TRIFORCE PERIPHERAL CROSSING SET; KRA CATHETER, CONTINUOUS FLUSH

Catalog Number KCXS-5.0-35-65-RB-0/0-HC

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

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 venous recanalization procedure, the sheath included in the triforce peripheral crossing set split at the tip.The user attempted to gain access in the right jugular vein using only the outer sheath of the device, without the inner catheter all the way inserted into the sheath to the tip, when the tip reportedly buckled.A photo provided by the customer shows a split in the tip of the sheath.As it was difficult to gain access in the right jugular vein, the physician tried the left jugular was able to gain access using the same sheath.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.

Event Description

No new patient or event information to report.

Manufacturer Narrative

Description of event: as reported, during a venous recanalization procedure, the sheath included in the triforce peripheral crossing set split at the tip.The user attempted to gain access in the right jugular vein using only the outer sheath of the device, without the inner catheter all the way inserted into the sheath to the tip, when the tip reportedly buckled.A photo provided by the customer shows a split in the tip of the sheath.As it was difficult to gain access in the right jugular vein, the physician tried the left jugular was able to gain access using the same sheath.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 (dhr), drawings, the instructions for use, manufacturing instructions, and quality control data.The complainant returned the complaint device to cook for investigation.Physical examination of the returned device showed: one kcxs set was received.The sheath was returned with the catheter lodged inside.The distal end of both the catheter and sheath were damaged, and the sheath tip was accordioned.No additional damage was noted.At this time, cook concluded that the device was manufactured within specification.The customer did not provide a lot number for investigation.A database search for lots sold to the customer in the past 3 years found two potential lots for the reported rpn.The dhr for the potential lots revealed no reported nonconformance's.A database search revealed no other complaints have been reported for the potential device lots.Cook concluded that there are no nonconforming products from the potential lots in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: intended use: ¿the triforce peripheral crossing set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions.This device is also intended for injection.This device is also intended for injection of radiopaque contrast media for purpose of angiography.¿ precautions: ¿the device should not be advanced into a vessel having a reference vessel diameter smaller than the sheath outer diameter.¿ ¿the device shall not be forced 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: ¿caution: advancing the support catheter into the sheath without a wire guide can easily cause kinking of the catheter.Use extra caution during this process.¿ ¿caution: be sure the wire guide tip is extended beyond the cxi support catheter tip at all times, and the cxi support catheter tip is extended beyond the flexor sheath tip at all times.¿ how supplied: ¿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 an unintended user error contributed to this incident.The customer stated that the physician was trying to advance the outer sheath without the inner sheath all the way to the tip of the device.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.

• Brand Name: TRIFORCE PERIPHERAL CROSSING SET
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11333042
• MDR Text Key: 266304878
• Report Number: 1820334-2021-00339
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K170931
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KCXS-5.0-35-65-RB-0/0-HC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1