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

Catalog Number CDC-45703-XP1A

Device Problem Kinked (1339)

Patient Problem Death (1802)

Event Date 01/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). This report is for the first in a series of three consecutive product issues with the same patient. The subsequent events have been reported under mdr #s 1036844-2016-00145 and 1036844-2016-00146, which was filed as an adverse event - death.

Event Description

It was reported the catheter was being placed into a patient during a code situation. When trying to gain access the guide wire kinked. As a result, another kit was opened and used. The patient expired. A separate mdr has been filed as a death for a subsequent product issue on this patient.

Manufacturer Narrative

(b)(4) device evaluation: the reported complaint of the guide wire became kinked during insertion was confirmed. The customer returned one guide wire. Visual examination revealed the distal end of the guide wire was kinked. An offset coil was observed within the j-bend, and just beyond the j-bend the wire was kinked to a 90 degree angle with biological material observed between the coils. Two additional kinks were also observed. The kinks were measured at 1. 5, 2. 1, 3. 5 and 4. 2 cm from the distal end. Microscopic examination confirmed that both welds were full and spherical. A manual tug test confirmed that both welds remain intact. The guide wire measured approximately 601 mm in the total length and exhibited an outside diameter (od) of 0. 799 mm. The returned guide wire was within specification for length and od. Instructions for use describe suggested techniques to minimize the likelihood of guide wire damage during use. A device history record review did not reveal any manufacturing related issues. Since the guide wire is always inserted through another component such as an introducer needle, ars syringe or introducer catheter and none of these components were 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 20 CM AGB
• 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: 5481295
• MDR Text Key: 39754909
• Report Number: 1036844-2016-00144
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2017
• Device Catalogue Number: CDC-45703-XP1A
• Device Lot Number: 23F15G1368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial