MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 20 CM AGB; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CDC-45703-XP1A

Device Problems Unraveled Material (1664); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the physician experienced difficulty when advancing the guide wire in the patient.He felt a small amount of resistance and continued to advance and was able to remove the needle.At which time, the catheter was placed over the wire.As he was removing the wire, it began to unravel.He immediately stopped and removed both the catheter and wire.As a result, another kit was used with no issues.There was no delay in treatment and no patient death or complications reported.

Manufacturer Narrative

(b)(4).Device evaluation: the report that the guide wire unraveled during use was confirmed.One 3-lumen 7fr x 20 cm catheter with an unraveled guide wire inserted through it was returned.Visual examination found kinks in the catheter body/guide wire located 10 and 16 cm below the juncture hub.The proximal end of the guide wire was unraveled with the core wire separated adjacent to the proximal weld.A 25 cm section of the guide wire was protruding from the distal end of the catheter.Several kinks/bends were observed on this section of guide wire.A manual tug test confirmed that the distal weld remains intact.The guide wire was removed from the catheter.The guide wire drawing specifies a length of 600 +/- 4 mm and a diameter of.788/.826 mm.The broken core wire was confirmed to be consistent with the graphic indicating that no pieces are missing.The diameter of the guide wire measured 0.799 mm, which met specifications.The catheter showed evidence of use and remained kinked after the guide wire was removed.The catheter graphic requires that a.035" dia guide wire must pass freely through the distal hub.A.035" gage wire was passed through the distal lumen with resistance only at the kinks in the catheter body.The instruction booklet describes suggested techniques to minimize the likelihood of other remarks: guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.A device history record review was performed and did not reveal any manufacturing related issues.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:1999 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, operational context caused or contributed to the event.No further action will be taken.

• Brand Name: PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: ARROWG+ARD CATHETER 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 ; 6103780131
• MDR Report Key: 5459789
• MDR Text Key: 38974100
• Report Number: 1036844-2016-00132
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F15G1168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2015
• 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