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 07/06/2023

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address= phone - (b)(6).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 an angioplasty of the right lower limb, the tips separated from a triforce peripheral crossing set's catheter and sheath.Access was obtained in the femoral artery and a contralateral approach was used to target the superficial femoral artery.The access site was not scarred; however, the bifurcation was "slightly angled" and calcium plaques were reported along the entire length of the stenosed superficial femoral artery.Although resistance was not encountered upon insertion or removal of the complaint device, resistance was encountered during insertion and removal of other devices through the sheath at the location of the calcified anatomy.A power injector was not used during the procedure.As the device was passed through the lesion, the catheter tip separated.As the triforce coaxial system was removed from the patient, the user noted that the sheath tip was also damaged.Photos provided by the customer appear to show sheath tip separation and possible sheath delamination.The catheter tip remains in the patient's superficial femoral artery; however, radiologic imaging did not identify any sheath material left in the patient.An unspecified coated stent was placed in the same region as the separated catheter tip.Per the user, placement of the stent was already a planned part of the procedure.The stent was not used to trap the catheter fragment in place.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

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a procedure involving an angioplasty of the right lower limb, the tips separated from a triforce peripheral crossing set's catheter and sheath.Access was obtained in the femoral artery and a contralateral approach was used to target the superficial femoral artery.The access site was not scarred; however, the bifurcation was "slightly angled" and calcium plaques were reported along the entire length of the stenosed superficial femoral artery.Although resistance was not encountered upon insertion or removal of the complaint device, resistance was encountered during insertion and removal of other devices through the sheath at the location of the calcified anatomy.A power injector was not used during the procedure.As the device was passed through the lesion, the catheter tip separated.As the triforce coaxial system was removed from the patient, the user noted that the sheath tip was also damaged.Photos provided by the customer appear to show sheath tip separation and possible sheath delamination.The catheter tip remains in the patient's superficial femoral artery; however, radiologic imaging did not identify any sheath material left in the patient.An unspecified coated stent was placed in the same region as the separated catheter tip.Per the user, placement of the stent was already a planned part of the procedure.The stent was not used to trap the catheter fragment in place.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: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.Photos of the complaint device were also inspected.The complaint device was not returned to cook for investigation; however, photos were provided by the customer.Photos show separation of both the cxi and sheath tips.Photos also show sheath delamination due to the severed tip.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for the final lot number.There were no non-conformances or additional complaints found on the cxi component lot.There were no additional complaints found on the sheath component lot.One relevant non-conformance was noted on the sheath component lot; however, all affected product was scrapped and there are 100% inspections in place to capture the non-conformance.The product ifu states ¿the device should 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.¿ although one relevant non-conformance was noted on the sheath component lot, all non-conforming product was scrapped, there are 100% inspections in place to capture this non-conformance, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot-related complaints have been received from the field.Therefore, it was concluded that there is no evidence that additional non-conforming product exists in house or in the field.The information provided upon review of the dmr, dhr, ifu, and investigation of device photos 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.Cook has 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 contributed to this event.The entire length of the superficial femoral artery (sfa) was calcified and stenosed throughout, and it is known that resistance was encountered upon advancement of devices through the sheath at the location of the calcified anatomy.Reportedly, as the catheter tip was passed through the calcified and stenosed lesion, the catheter tip separated.It is possible that the diameter of the stenosed and calcified sfa lumen was not large enough to accommodate the complaint device.It is also possible that the lumen/tip of the sheath was damaged as other devices were advanced through the sheath within the stenosed and calcified sfa.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.

Event Description

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

• 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: 17460614
• MDR Text Key: 320408503
• Report Number: 1820334-2023-01026
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002564176
• UDI-Public: (01)00827002564176(17)240730(10)14012414
• 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: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• 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: 14012414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2021
• 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: BALLOON, MIKAELSON CATHETER; COOK RPC-35-260, RLPC-35-260, THSCF-35-260-3-AES; RAABE SHEATH, CXI
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male