MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. PI CVC KIT: 3-L 7 FR X 16 CM AGB+; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CA-42703-P1A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample will be returned for evaluation.This report is for the first in a series of two consecutive product problems with the same patient.The second issue has been reported under mdr # 3003737899-2016-00038.

Event Description

It was reported the procedure was being performed in the emergency department.During insertion into the patient's right femoral the clinician experienced an issue with the guide wire kinking.As a result, a second kit was opened.Follow up information confirmed the guide wire kinked when it was being inserted through the needle.

Manufacturer Narrative

Qn#(b)(4).Device evaluation: the reported complaint of the guide wire became kinked during insertion into the introducer needle could not be confirmed.The customer returned one guide wire and multiple other components in an opened kit.The introducer needle was not returned.Visual examination of the guide wire revealed one kinks at the distal end of the wire and the j- bend appeared opened.The kink was measured at 2.9 cm from the distal weld.Microscopic examination confirmed the kink and also confirmed that both welds were full and spherical.A manual tug test confirmed that both welds remain intact.The guide wire measured approximately 450 mm in the total length and exhibited an outside diameter (od) measured 0.793 mm.The returned guide wire was within specification for length and od per guide wire graphic (length: 450 - 458 mm and od: 0.788- 0.826mm).The other returned components, catheter, arrow raulerson syringe(ars) and dilator, all appeared used since dried blood was observed on both the outside and inside of these components.Functional testing was performed with the returned guide wire and each of these components separately.The guide wire passed through each component with no resistance.The instructions for use describe suggested techniques to minimize other remarks: the likelihood of guide wire damage during use.The device history record review was performed and did not reveal any manufacturing related issues.Since the introducer needle was not returned, the probable cause of this issue could not be determined.No further action will be taken.

• Brand Name: PI CVC KIT: 3-L 7 FR X 16 CM AGB+
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5892020
• MDR Text Key: 52615512
• Report Number: 3003737899-2016-00037
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: CA-42703-P1A
• Device Lot Number: 13F16A0201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1