MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 7 FR X 20 CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CS-27702-E

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

Patient Problem Injury (2348)

Event Date 01/31/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that after advancing the catheter in the icu, the guidewire could not be withdrawn.As a result, the skin was cut near the insertion site and both the catheter and guidewire were simultaneously removed.It was at that time that the guidewire was found deformed.A new kit was opened and used without issue.A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.

Manufacturer Narrative

(b)(4).Device evaluation: it was reported that the guide wire could not be withdrawn from the catheter was confirmed.Returned was one guide wire inserted through a 7 fr x 20 cm catheter.Visual examination revealed that the guide wire was protruding 24 cm from the distal end of the catheter.Functional testing confirmed that both end welds and the core wire were intact.The guide wire was removed from the catheter, but the catheter tip remained deformed.Severe kinks were observed 24, 26, and 50 cm from the j-tip and 1.5 cm from the weld on the straight end.The guide wire graphic specifies the length at 600 +/-4 mm and the outside diameter at.788/.826 mm, which the returned guide wire was confirmed to be consistent with the graphic.A gage wire was passed through the distal lumen indicating no blockages or restrictions that would prevent passage of a.032 guide wire through an undamaged catheter.Instruction booklet describes suggested techniques for catheter insertion including instructions for guide wire removal if resistance is encountered during removal from the catheter.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 the event.No further action will be taken.

• Brand Name: CVC SET: 2-LUMEN 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 ; 6103780131
• MDR Report Key: 5411477
• MDR Text Key: 37516755
• Report Number: 1036844-2016-00076
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F15G1049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• 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
• Patient Outcome(s): Required Intervention