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

Catalog Number CDC-45703-A1A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the physician experienced difficulty during insertion.He attempted to remove the wire once it was threaded over the catheter.At which time, the spring wire guide unraveled and the catheter and wire were removed as one.Another kit was used and placed successfully.There was 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-l 7 fr x 20 cm catheter with an unraveled guide wire inserted through it was returned.Visual examination revealed a 2mm section of the guide wire was protruding from the catheter tip.An unraveled section of the guide wire was protruding from the proximal end of the distal luer hub.Microscopic examination determined that the core wire is broken adjacent to the distal weld.A manual tug test confirmed that the proximal weld remains intact.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 guide wire graphic; therefore, no pieces appear to be missing.The diameter of the guide wire measured 0.797 mm.The catheter showed evidence of use but no defects or anomalies were observed.A.035" gage wire was passed through the distal lumen which meets the requirements of the catheter graphic.Instructions for use describes suggested techniques to mini mize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against other remarks: 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.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: 3-L CVC KIT: 7 FR X 20 CM
• 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: 5551141
• MDR Text Key: 41986486
• Report Number: 1036844-2016-00202
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993691
• 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: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: CDC-45703-A1A
• Device Lot Number: 23F15F1240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• 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