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

Model Number	G52542
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = k160884.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.
Event or Problem Description
It was reported, a (b)(6) male was undergoing an unspecified procedure via the left anterior tibial artery.After the third removal from the patient's anatomy, a cxi support catheter was found to have torn at the distal tip,1mm past the radiopaque marker.The highly calcified target lesion was located in the superficial femoral artery.Left pedal approach was used to gain access to the lesion.Other devices in use were another manufacturer's 4fr sheath, and an unspecified 0.35 wire guide.A power injector was not used.No resistance was felt during insertion or removal of the complaint device and the fitting was not wiped down with any solutions.During this same procedure, a cook balloon catheter was inflated inside an old stent and ruptured.Please reference medwatch 1820334-2019-01259 for details of this event.The procedure was successfully completed without patient adverse effect.No further procedures were needed.The complaint device has not been release from the complaint facility.It is not known if it will be returned to aid in the manufacturer's investigation of this event.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿ instructions, quality control, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.However, while reviewing the subassembly lot of this device, a potentially related nonconformance was noted.While this nonconformance may be related to the reported failure, it should be noted that the affect unit was scrapped and not replaced prior to order completion.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawings, specifications, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states "the 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." based on the information provided and no product returned, investigation has concluded that this event could not be traced to the device but to the patient¿s condition.Reportedly, the target area was highly calcified.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: CXI SUPPORT CATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8640866
• Report Number: 1820334-2019-01258
• Device Sequence Number: 13866724
• Product Code: KRA
• UDI-Device Identifier: 00827002525429
• UDI-Public: (01)00827002525429(17)220201(10)9490876
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: G52542
• Device Catalogue Number: CXI-4.0-35-135-P-NS-0
• Device Lot Number: 9490876
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 07/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR