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

Model Number G51583

Device Problems Peeled/Delaminated (1454); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) number = k161801.(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, three devices malfunctioned during a balloon angioplasty: the coating came off a roadrunner uniglide hydrophilic wire guide (medwatch 1820334-2019-00544); the inner portion of the crosscath support catheter was stripped, and the tip of a broke off in the patient's anatomy (refer to this report, medwatch 1820334-2019-00545); and an advance 14 lp low profile balloon catheter broke inside a sheath (medwatch 1820334-2019-00546).This report references the crosscath support catheter: it was reported, during a balloon angioplasty, a roadrunner uniglide hydrophilic wire guide was used and the coating of the wire came off.The wire was able to be removed with the coating and the device was placed aside.Another manufacturer's wire was used to complete the intended use of the wire.During the same procedure, a crosscath support catheter was used over a wire (wire details not specified).While attempting to cross a very difficult stenosis, the wire was being removed and stripped the inner portion of the catheter and the tip of the catheter broke off inside the patient.The broken tip portion was removed using another manufacturer's snare device.During removal of the advance 14 lp low profile balloon catheter, the user pulled with excessive force and the balloon broke within a 6fr 45cm curved cook hiflex ansel sheath.The balloon and sheath were removed as a unit.The case was aborted at this time.The access site was the common femoral artery and the patient's anatomy was described as tortuous and calcified.The patient did not experience any adverse effects as a result of these occurrences and is described as being in stable condition.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one crosscath support catheter (cxc3.4-2.2-18-135-p-ns-0) was returned to cook for investigation.The device was returned in two separate pieces.The catheter was separated 2.6cm from the strain relief.Additionally, the catheter was elongated at the distal end with a wire guide inserted.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 two nonconforming events which could potentially contribute to this failure mode.These nonconformances were for shaft damage.While these may have been related to the reported failure, it should be noted that the affected units were scrapped prior to order completion.It should also be noted that the only other complaint associated with this lot number was pr 255542, which occurred in the same event, on the same device.Furthermore, reviews of the manufacturer¿s instructions, documentation, drawing, and quality control procedures were conducted, and no gaps were discovered.Through this, cook has confirmed that appropriate measures are in place to prevent this failure mode.Moreover, an ifu is provided with the 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." it goes on to say ¿do not advance catheter without the wire extending out of the distal tip." based on the information provided and the examination of the returned product, investigation has concluded that this event cannot be traced to the device, but instead lies with the patient¿s condition as a ¿very difficult stenosis¿ was reported.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.

• Brand Name: CROSSCATH SUPPORT CATHETER
• Type of Device: KRA CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8399963
• MDR Text Key: 138122781
• Report Number: 1820334-2019-00545
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00827002515833
• UDI-Public: (01)00827002515833(17)210703(10)8994584
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2021
• Device Model Number: G51583
• Device Catalogue Number: CXC3.4-2.2-18-135-P-NS-0
• Device Lot Number: 8994584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 04/16/2019
• Supplement Dates FDA Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention