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

Model Number	G51574
Medical Device Problem Codes	Stretched (1601); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.Pma/510(k) number: k161801.Device evaluation has begun; however, a conclusion is not yet available.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
It was reported, an (b)(6) male was undergoing an aortoiliiofemoral (aif) procedure of the calcified posterior tibial artery via pedal access when another manufacturer's 0.14 guide wire became stuck inside the crosscath support catheter.The crosscath support catheter was removed.Details reportedly are unavailable; therefore, it is unknown if another crossing catheter was used during the procedure.The physician was unable to treat the target lesion via the pedal access despite continued attempts to cross it.The access point was changed to the groin and the procedure was successfully completed.The patient reportedly was recovering as expected and did not experience any adverse effects as a result of this occurrence.Upon receipt of the complaint device, it was noted by the complaint investigator on (b)(4) 2019 to have "elongation on the distal section of the catheter.The elongation was approximately 56.6cm in length, measuring from distal tip.Under the strain relief a severely twisted section was noted and measured approximately 2cm in length.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, drawings, device history record, documentation, manufacturing instructions, quality control, and visual inspection of the returned device was conducted during the investigation.The used complaint device was returned with a competitor's wire lodged in it.All marker bands were present.Elongation and twisting were noted which were previously reported.Additionally, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows one nonconformance for shaft damage; however, the affected units were scrapped.There is no evidence to support non-conforming product in-house or in the field.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite conclusion for the event could not be established.The patient's calcified anatomy may have been a contributing factor.Per the quality engineering risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.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: CROSSCATH SUPPORT CATHETER
• Common Device Name: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8395609
• Report Number: 1820334-2019-00548
• Device Sequence Number: 2765332
• Product Code: KRA
• UDI-Device Identifier: 00827002515741
• UDI-Public: (01)00827002515741(17)211023(10)9254935
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/05/2019

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: 10/23/2021
• Device Model Number: G51574
• Device Catalogue Number: CXC3.0-1.9-14-150-P-NS-0
• Device Lot Number: 9254935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR