MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CDC-45703-XP1A

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Potential lot# 23f17a0810.

Event Description

The customer alleges that the guidewire kinked upon insertion.No patient injury or consequence.No delay in therapy.

Manufacturer Narrative

Qn#(b)(4).The customer returned a guide wire in an advancer.The guide wire was initially stuck in the straightening tube by dried blood.Once the guide wire was removed it was observed to be kinked at 1.8, 2.5, 12 and 15cm from the bottom of the j-bend.The outside diameter (od) of the guide wire measured 0.800mm, which met specification.The length of the guide wire measured 60.2cm, which is consistent with the graphic.A manual tug test confirmed that both welds were intact.A device history record (dhr) review was performed on the guide wire based on sales history and did not reveal any manufacturing related issues.The report that the guide wire kinked during insertion was confirmed through examination of the returned sample.The guide wire was kinked at multiple locations.A dhr review was performed based on sales history and it did not reveal any manufacturing related issues.Since the guide wire is always inserted through another component during the procedure and no other components were returned, the probable cause of this issue could not be determined.

Event Description

The customer alleges that the guidewire kinked upon insertion.No patient injury or consequence.No delay in therapy.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6471983
• MDR Text Key: 72443708
• Report Number: 1036844-2017-00155
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• 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
• Patient Sequence Number: 1