MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CDC-45703-P1A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the procedure was being performed in the emergency room.The introducer hung in the catheter and would not retract.As a result, the catheter and wire were removed and replaced.There was a delay in treatment and no patient death was reported.Follow up information states during insertion, the clinician was not able to remove the guide wire from the catheter.Another kit was used to complete the catheter placement successfully.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the report of difficulty removing the guide wire from the catheter was confirmed.One 3-lumen 7fr x 20 cm catheter with a guide wire inserted through it was returned.The proximal end of the guide wire was unraveled.The distal (j-tip) end of the guide wire was protruding 14 cm beyond the catheter tip and was intact.The guide wire was removed from the catheter.A manual tug test determined that distal weld is intact with the core wire.Numerous kinks/bends were observed on the distal end of the guide wire.Microscopic inspection determined that the core wire was broken adjacent to the proximal weld.The guide wire graphic specifies an outside diameter of.788/.826 mm and a length of 600 +/-4 mm.The guide wire length was confirmed to be consistent with the graphic.The outside diameter measured.796 mm, which met specifications.The catheter body was kinked 10.5 cm from the juncture hub.The catheter drawing requires that a.035" dia guide wire must pass from the catheter tip through the distal extension line hub.An.035" gage wire was passed through the distal lumen with some resistance encountered at the kink in the catheter body.Other remarks: the instructions for use describes suggested techniques to minimize the likelihood of guide wire damage during use.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.The device history records for were reviewed 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: MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8"
• 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: 5725073
• MDR Text Key: 48255696
• Report Number: 1036844-2016-00324
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: CDC-45703-P1A
• Device Lot Number: 23F15L0748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• 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