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

Model Number G18372

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

Customer name and address= (b)(6).Pma/510(k) number = k122796.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 an angiography, atherectomy, and drug-coated balloon angioplasty procedure involving a patient with a history of peripheral artery disease, green matter came out of a cxi support catheter after flushing the device.The catheter was opened and flushed prior to use.No green matter was noted upon the initial flush.The user attempted to advance the catheter over another manufacturer's 0.014 inch wire guide; however, the catheter would not track over the wire.The catheter was removed and flushed again, at which time green matter came out of the catheter.There was no peeling or flaking noted on the wire guide.The complaint device was discarded and a new cxi catheter was opened and used to complete the procedure.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

Additional information- section c.H6: ec methods code desc.- 5: communication/interviews (4111).Event summary: as reported, during an angiography, atherectomy, and drug-coated balloon angioplasty procedure involving a patient with a history of peripheral artery disease, green matter came out of a cxi support catheter after flushing the device.The catheter was opened and flushed prior to use.No green matter was noted upon the initial flush.The user attempted to advance the catheter over another manufacturer's 0.014 inch wire guide; however, the catheter would not track over the wire.The catheter was removed and flushed again, at which time green matter came out of the catheter.There was no peeling or flaking noted on the wire guide.The complaint device was discarded and a new cxi catheter was opened and used to complete the procedure.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, drawings, the instructions for use, manufacturing instructions, and quality control data.One used and damaged cxi catheter was returned for investigation.Biomatter was present on the returned device.The returned device had multiple kinks.There were two kinks in the device shaft located at 47.9cm and 50.8cm from the strain relief.Additionally, there was a kink under stain relief 9mm from the hub.Another kink was found located 14.5cm from the distal tip.The wire guide used in the procedure was not returned.A 0.014" wire guide was used from the lab for testing.The 0.014" wire guide was inserted into the distal tip.The wire guide would not fully advance through the distal tip.Biomatter was found inside the catheter, but no visible green matter was present.The catheter could not be flushed.The wire was attempted to be inserted into the hub; however, the wire was unable to be advanced.Although no green matter was observed during device analysis, the complaint is confirmed based on difficultly advancing the wire through the catheter.A review of the device history record 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 lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu) provided with the device caution, ¿this catheter should not be advanced 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.¿ the ifu further states, "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 a definitive cause for this event could not be determined.A capa was initiated to further investigate and address this failure mode.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.

Event Description

No new patient or event information to report.

• 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: 9322725
• MDR Text Key: 194202445
• Report Number: 1820334-2019-02880
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002183728
• UDI-Public: (01)00827002183728(17)220729(10)9911309
• Combination Product (y/n): N
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2022
• Device Model Number: G18372
• Device Catalogue Number: CXI-2.3-14-90-ANG
• Device Lot Number: 9911309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.014 ABBOTT COMMAND WIRE