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

Catalog Number KCXS-5.0-35-100-RB-0/DAV-HC

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

Patient Problem Foreign Body In Patient (2687)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

D10: medtronic trailblazer angled support catheter.035x90cm, penumbra engine with indigo system/cat kit 12french.E3: occupation = inventory manager.H3: device evaluated by mfg = other (81) - 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.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.

Event Description

As reported, during a procedure involving a venogram with embolization of the ovarian vein, a triforce peripheral crossing set's sheath unraveled and separated prior to the embolization procedure.The patient reportedly had "hardened" vascular disease.Access was obtained in the right groin.The physician advanced the triforce with and without the 0.035-inch wire guide.Multiple other devices were used during the procedure, including wire guides, a support catheter, and biopsy forceps.In the middle of the procedure, while attempting to cross an occlusion, the tip of the sheath reportedly unraveled and separated from the device.Access was then obtained in the left groin, and a cook snare and another manufacturer's mechanical thrombectomy system were used to retrieve some of the fragments; however, two fragments were left in the patient around the iliac vein, as the user believed that the limit of x-ray emission had been reached and that the patient could experience harm if they continued.Reportedly, the physician will schedule the patient for another procedure to retrieve the fragments in upcoming weeks.The patient was not hospitalized.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 tip was separated into fragments and sheath delamination was noted.

Event Description

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

Manufacturer Narrative

Summary of event: as reported, during a procedure involving a venogram with embolization of the ovarian vein, a triforce peripheral crossing set's sheath unraveled and separated prior to the embolization procedure.The patient reportedly had "hardened" vascular disease.Access was obtained in the right groin.The physician advanced the triforce with and without the 0.035-inch wire guide.Multiple other devices were used during the procedure, including wire guides, a support catheter, and biopsy forceps.In the middle of the procedure, while attempting to cross an occlusion, the tip of the sheath reportedly unraveled and separated from the device.Access was then obtained in the left groin, and a cook snare and another manufacturer's mechanical thrombectomy system were used to retrieve some of the fragments; however, two fragments were left in the patient around the iliac vein, as the user believed that the limit of x-ray emission had been reached and that the patient could experience harm if they continued.Reportedly, the physician will schedule the patient for another procedure to retrieve the fragments in upcoming weeks.The patient was not hospitalized.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 tip was separated into fragments and sheath delamination was noted.Investigation evaluation: reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.Pieces of the sheath tip were missing, and several small particles/fragments were returned, possibly from the sheath tip.A document-based investigation evaluation was performed.A review of the device history record found no relevant non-conformances on the lot.A review of complaint history found no additional complaints for this lot number.The product ifu states "be sure the wire guide tip is extended beyond the cxi support catheter tip at all times, and that the cxi support catheter tip is extended beyond the flexor sheath tip at all times." the information provided upon review of the device master record (dmr), dhr, ifu, and investigation of the returned device suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy and procedural issues related to unintended user error contributed to this event.The patient reportedly had hardened vascular disease and the tip separated while crossing an occlusion.The user reported that the sheath was advanced both with and without the wire guide during the procedure.The ifu cautions "be sure the wire guide tip is extended beyond the cxi support catheter tip at all times, and that the cxi support catheter tip is extended beyond the flexor sheath tip at all times." the risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.

• Brand Name: TRIFORCE¿ PERIPHERAL CROSSING SET
• 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: 17618521
• MDR Text Key: 321922822
• Report Number: 1820334-2023-01146
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002564176
• UDI-Public: (01)00827002564176(17)240705(10)14000731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: KCXS-5.0-35-100-RB-0/DAV-HC
• Device Lot Number: 14000731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2021
• 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: ARGON MEDICAL BIOPSY FORCEP; COOK COPE WIRE, TRI-FORCE WIRE; COOK MEDICAL AMPLATZ GOOSENECK MICROSNARE KIT; SAHEAD CROSS LEAD 0.35X 300CM
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female