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

Catalog Number AK-42703

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report is for the first in a series of two consecutive product problems with the same patient.The first issue has been reported under mdr # 1036844-2016-00668.

Event Description

It was reported that in the or during insertion of the guide wire into the needle (from the second kit), the guide wire kinked again.There was no reported delay, death, or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4).Device evaluation: the customer reported that during insertion of the guide wire through the introducer needle the guide wire becomes jammed.This issue was confirmed.The customer returned one kinked guide wire.The introducer needle was not returned.The returned guide wire was examined and measured.Visual examination revealed the guide wire exhibited four kinks and the j-bend was partly opened.Microscopic examination confirmed four kinks in the wire and one had offset coils.Microscopic examination also confirmed that both welds were full and spherical.A manual tug test was performed and it revealed that both welds were intact.The kinks were measured at 21.0, 22.0, 23.5 and 35.1 cm from the distal weld.The length of the guide wire measured 45.6 cm and the outside diameter (od) measured 0.800 mm.Both measurements meet specification per the guide wire graphic (length: 450-458 mm and od: 0.788-0.826mm).The ifu for this product cautions that if resistance is encountered while advancing or withdrawing the guide wire do not use force and warns not to retract the guide wire against the edge of needle while in a vessel to minimize spring guide wire damage.A device history record review was performed with no other remarks: relevant findings.The investigation found no evidence to suggest a manufacturing related cause.The probable cause of the guide wire kinking during insertion could not be determined based upon the information provided and without a complete sample.No further action will be taken.

• Brand Name: CVC KIT: 3-LUMEN 7 FR X 16 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: 6171328
• MDR Text Key: 62339978
• Report Number: 1036844-2016-00669
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K993691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: AK-42703
• Device Lot Number: 23F16C1034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2016
• 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