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

Catalog Number CXI-2.6-18-90-P-NS-ANG

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that during a percutaneous transluminal angioplasty of the anterior tibial artery (ata), the cxi support catheter separated into three pieces.Access was made into the ata and a resistance was felt making it impossible to advance the catheter.The physician attempted to pull the catheter back but felt it was stuck.More force was exerted in order to remove it.The catheter was finally removed and was noted to be separated into three pieces.According to the initial reporter, 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.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the dimensional verification, documentation, drawing, instructions for use (ifu), quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the device was separated into 3 segments.The first segment (which included the proximal hub) measured 74.6 cm in length.The larger of the two other segments measured 12.0 cm in length (including the distal tip, which also showed the shaft to be twisted to the point of separation at a distance of 3.1 cm from the distal tip).The smaller segment measured 2.8 cm in length, and showed accordion-like damage.Upon pulling the strain relief down, no damage to the shaft under the strain relief was noted.An attempted functional test was unable to pass a 0.018" wire guide through the two larger separated segments of the catheter; however it did pass through the smallest segment, which measured 2.8 cm.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.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.Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the dimensional verification, documentation, drawing, instructions for use (ifu), quality control, specifications, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the device was separated into 3 segments.The first segment (which included the proximal hub) measured 74.6 cm in length.The larger of the two other segments measured 12.0 cm in length (including the distal tip, which also showed the shaft to be twisted to the point of separation at a distance of 3.1 cm from the distal tip).The smaller segment measured 2.8 cm in length, and showed accordion-like damage.Upon pulling the strain relief down, no damage to the shaft under the strain relief was noted.An attempted functional test was unable to pass a 0.018" wire guide through the two larger separated segments of the catheter; however it did pass through the smallest segment, which measured 2.8 cm.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.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: CXI SUPPORT CATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7468393
• MDR Text Key: 106760680
• Report Number: 1820334-2018-01132
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K072724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

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: CXI-2.6-18-90-P-NS-ANG
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCIENTIFIC V-18 WIRE; BOSTON SCIENTIFIC V-18 WIRE
• Patient Age: 63 YR