MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. RA CATH KIT: 20 GA X 1-1/2"; RADIAL ARTERY PRODUCTS

Catalog Number AK-04220

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem Hematoma (1884)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the catheter was being placed into the patient's right radial artery in the emergency department.The catheter was inserted into the artery successfully, pulsatile flashback was reported as expected.When attempting to thread the guide wire resistance was met.When the clinician attempted to thread the catheter they were unsuccessful.At which time it was determined that the only option was to remove the device.The clinician moved the unit as a whole back and forth a bit until it released and the wire and catheter were removed intact.The patient had a large hematoma and the clinician held pressure for approximately 25 minutes.The patient was then sent to a different department.There was a delay in treatment with no patient harm and no patient complications reported.

Manufacturer Narrative

(b)(4).Device evaluation: the report that the guide wire was damaged during insertion was confirmed.Returned was a radial artery (ra) ca theorization device consisting of a guide wire, advancer tube, and needle.The catheter was not returned.The handle to advance the guide wire was fully retracted into the advancer.The guide wire was unraveled at the distal end and the coil wire was protruding from the distal tip of the needle.The sample was examined microscopically.The distal weld was missing from the coil wire.There was damage inside the needle bevel and a depression on the outside of the cannula.Dried blood was observed inside the needle.Attempts to advance the guide wire out of the needle were unsuccessful and resulted in additional damage to the wire.The instruction booklet provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.It contains the precaution not to force feed the guide wire if resistance is encountered while advancing the guide wire.It also contains the warning not to retract the guide wire against the edge of the needle while in the vessel to minimize the risk of guide wire damage.A review of the device history records did not reveal any manufacturing related issues.Based on the condition of the other remarks: sample and the report of difficulty during insertion, operational context caused or contributed to this event.No further action will be taken.

• Brand Name: RA CATH KIT: 20 GA X 1-1/2"
• Type of Device: RADIAL ARTERY PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5898987
• MDR Text Key: 52851146
• Report Number: 1036844-2016-00483
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K810675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: AK-04220
• Device Lot Number: 23F16E0643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2016
• 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