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

Model Number	G50002
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during an endovascular treatment procedure involving occlusion of an unknown pre-existing stent, another manufacturer's 0.014-inch wire guide perforated the side of a cxi support catheter.The left common femoral artery was used for access, and a contralateral approach was used.The bifurcation was not tight.The user inserted and advanced the other manufacturer's wire guide into the cxi; however, the wire guide perforated the catheter near the tip of the device.Another manufacturer's device was then used to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Initial report: as reported, during an endovascular treatment procedure involving occlusion of an unknown pre-existing stent, another manufacturer's 0.014-inch wire guide perforated the side of a cxi support catheter.The left common femoral artery was used for access, and a contralateral approach was used.The bifurcation was not tight.The user inserted and advanced the other manufacturer's wire guide into the cxi; however, the wire guide perforated the catheter near the tip of the device.Another manufacturer's device was then 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, documentation, the instructions for use, manufacturing instructions, and quality control data.One device was returned for investigation.Physical examination of the returned device showed one catheter was returned with biomatter present.Upon visual inspection, 3cm of the distal end of the catheter has multiple kinks.No perforation could be detected on the device.A 0.018¿ wire was used to advance into the catheter and the wire met resistance at the kinked section of the catheter.The wire would not fully advance through the catheter.A review of the device history record found one non-conformance related to the reported failure mode.The non-conformance is for ¿shaft, damage¿ with a descriptive comment ¿received bent¿ that affected a quantity of two which were scrapped.A review of complaint history records shows no other complaints associated with the complaint device lot.As there are adequate inspection activities established and objective evidence that the dhr was fully executed.It was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: -¿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.¿ how supplied: -¿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.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specification.If the patient¿s anatomy was tortuous this could have caused the catheter to perforate.The device is to be used with a 0.018¿ wire guide, but was used with a 0.014¿ wire guide.Though the diameter is smaller.This would not perforate the catheter.The investigation conclusion for this complaint is cause traced to a component failure without a manufacturing or design deficiency.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.
Additional Manufacturer Narrative
Additional information received 23jun2020: d10, h3; the device will be returned to cook.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 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: 10138038
• Report Number: 1820334-2020-01100
• Device Sequence Number: 11342589
• Product Code: KRA
• UDI-Device Identifier: 00827002500020
• UDI-Public: (01)00827002500020(17)220724(10)9901080
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160884
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2020

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: 07/24/2022
• Device Model Number: G50002
• Device Catalogue Number: CXI-2.6-18-90-P-NS-ANG
• Device Lot Number: 9901080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 06/23/2020; 08/12/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 07/06/2020; 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.014-INCH GLADIUS/ASAHI INTECC; 0.014-INCH GLADIUS/ASAHI INTECC.