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

Catalog Number CXC4.8-3.7-35-135-P-NS-0

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

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

Event Date 01/04/2018

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 lower extremity angiogram, a flexor ansel sheath (6 fr, 45 centimeter (cm) length) was up and over the aortic bifurcation.A cook medical connors wire guide was advanced through the sheath into the patient's superficial femoral artery (sfa), and the crosscath support catheter was advanced over the wire guide to the distal sfa.The wire guide was attempted to be removed and became stuck on the catheter; the wire guide and catheter were able to be removed together.It was noted that there was a high amount of tension placed on the catheter while the wire guide was attempted to be removed.Another wire guide and catheter were then opened and advanced to the distal sfa.Following successful complete of the procedure, the crosscath support catheter hub was observed to be separated.The patient was noted to have calcified vessels.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, drawing, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the hub did not separate; ho hub defects were noted.9.0 mm of accordion damage was observed immediately distal to the hub of the device.Additionally, 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 showed one nonconforming event which could contribute to this failure mode.It should be noted there was one other reported complaint for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, the reported failure mode was not detected.The complaint cannot be confirmed.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• Brand Name: CROSSCATH SUPPORT CATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7183432
• MDR Text Key: 97109982
• Report Number: 1820334-2018-00107
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002515819
• UDI-Public: (01)00827002515819(17)201004(10)8266383
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

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: CXC4.8-3.7-35-135-P-NS-0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1