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

Catalog Number	CXI-2.3-14-90-ANG
Medical Device Problem Codes	Material Separation (1562); Fitting Problem (2183)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pma/510(k) number = k122796.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
It was reported that during a procedure, the cxi support catheter hub broke off during removal of the device and catheter tubing separated.The physician unsuccessfully attempted to cross the patient's chronic total occlusion (cto) from an up and over approach, then proceeded to gain access from the dorsalis pedis using a pedal micropuncture and tried to cross the cto retrograde.A 25 gauge approach cto microguide wire without the pedal sheath, using the cxi support catheter over the mircroguide wire, was used to successfully cross the cto with noted difficultly.The microguide wire was advanced through the cto, and as the physician attempted to remove the cxi support catheter it felt stuck to the microguide wire, prompting him to forcibly pull on the catheter hub.The catheter hub completely broke off of the catheter, and the physician attempted removal of the catheter without the hub by pulling on it for 20- 30 minutes.The catheter was able to be completely removed; however it broke into pieces during removal over the microguide wire as the physician had to use force in order to maintain wire access.The microguide wire was snared from the up and over approach, as initially intended, and the procedure was successfully completed.According to the initial reporter, the no device portion remained in the patient, and the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, instructions for use (ifu), quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the device was returned in four separate sections; the hub was not returned.Section 1 (59.2 cm in length) had 3 cm of damage present on one end.Section 2 (11.6 cm in length) had 2 mm of accordion damage.Section 3 (4.8 cm in length) had 8 mm of accordion damage.Section 4 (13.3 cm in length) had 4.2 cm of accordion damage on one end.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Although a review of subassembly work orders for device components revealed three nonconformances which may be related to the reported failure mode, a review of the device history record for the finished lot showed no nonconforming events 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, a definitive root cause could not be determined.It is likely, however, that patient condition was related to the event.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 7095348
• Report Number: 1820334-2017-04354
• Device Sequence Number: 19128366
• Product Code: KRA
• UDI-Device Identifier: 00827002183728
• UDI-Public: (01)00827002183728(17)181203(10)6425324
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CXI-2.3-14-90-ANG
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 04/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention