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 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). This report is for the second in a series of two consecutive product problems with the same patient. The first issue has been reported under mdr # 1036844-2016-00240.

Event Description

The physician was removing the spring wire guide and again, the spring wire guide began to unravel. The catheter and wire were removed as one. The physician then used a quad lumen catheter and it was placed successfully. There was no patient death or complications reported.

Manufacturer Narrative

(b)(4). Device evaluation: the report that the guide wire during use was confirmed. One guide wire was returned for analysis. The catheter involved in the incident was not returned. Visual/tactile examination found numerous kinks/bends over the length of the guide wire body and that the core wire was broken. Microscopic examination found that the core wire was broken adjacent to the proximal (straight) weld. The proximal weld remains attached to the coil wire. A manual tug test confirmed that the core wire remains intact with the distal weld and coil wire. The guide wire drawing specifies a length of 600 +/- 4 mm and a diameter of. 788/. 826 mm. The length of the guide wire / core wire was determined to be consistent with the drawing. The outside diameter measured 0. 799, which met specifications. The instruction booklet describes suggested techniques to minimize the likelihood of guide wire damage during use. The instructions for use (ifu) state that if resistance is encountered when attempting to remove the guide wire after catheter placement, guidewire may be kinked around the tip of the catheter within vessel. In this circumstance, pulling back on the guide wire may result in undue force being applied resulting in other remarks: guide wire breakage. The ifu also state that if resistance is encountered, withdraw the catheter relative to the guide wire about 2-3 cm and attempt to remove guide wire. If resistance is again encountered, remove guidewire and catheter simultaneously. The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking. A device history record review was performed based on sales history and did not reveal any manufacturing related issues. 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
• MDR Report Key: 5623686
• MDR Text Key: 44136449
• Report Number: 1036844-2016-00241
• 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

• Type of Report: Initial,Followup
• Report Date: 04/25/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial