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

Catalog Number CA-45703-P1A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the procedure was being performed in the emergency department.During insertion, the clinician was threading the catheter over the guide wire.She tried to remove the wire but it would not come out.The physician had to remove both the catheter and wire as one.A different insertion site was then accessed and a cook guide wire was used to place the catheter successfully.There was a delay in treatment but no patient harm and no patient death or complications reported.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the report that the guide wire kinked during use was confirmed.The customer returned one guide wire and one picc catheter.The returned sample was received with the guide wire inserted through the catheter and protruding from both ends of the catheter.Visual examination revealed that the distal end of the guide wire has multiple kinks and that the guide wire is unraveled from the proximal end.The catheter appeared typical but used.A manual tug test confirmed that the distal weld was intact but the proximal weld was found to be broken.Microscopic examination revealed that the core wire was broken on the proximal end and that necking and discoloration were observed on the end of the core wire.Microscopic examination also revealed that the proximal weld was at the end of the coil wire and both welds of the guide wire were full and spherical.No other damage was observed with either component.The guide wire measured approximately 59.4 cm which was difficult to measure due to the severe kinks but is consistent with the length specifications of 59.6 - 60.4 cm per guide wire graphic.The outside diameter of the guide other remarks: wire measured 0.797 mm, which is within the specification of 0.0.788- 0.826 mm.Per guide wire graphic.The guide wire was removed from the catheter and a 0.032 " lab inventory long pin gage was inserted through the distal lumen without resistance indicating that the catheter was not obstructed.The instructions for use describe suggested techniques to minimize the likelihood of 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.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.A device history record review was performed and did not reveal any manufacturing related issues.Based on these circumstances, operational context caused or contributed to this issue.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: 5618528
• MDR Text Key: 43992405
• Report Number: 1036844-2016-00233
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

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: 05/31/2017
• Device Catalogue Number: CA-45703-P1A
• Device Lot Number: 23F15G0946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2015
• 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