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

Catalog Number CDC-42703-XP1A

Device Problem Entrapment of Device (1212)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).No sample is available for evaluation.(b)(4).

Event Description

At home, the patient suffered a cardiac arrest.The paramedics were called and resuscitated the patient.Patient was brought to emergency department and diagnosed with posterior myocardial infarction.Emergency department physician attempted to place a central line in the femoral artery.The guide wire became stuck in the vessel.Patient began coding again.After resuscitation, patient taken to ct for head ct scan and then emergent craniotomy.The next day, a cardiovascular surgeon removed guide wire at the bedside.

• 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 INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: john george ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5420339
• MDR Text Key: 37837126
• Report Number: 1036844-2016-00101
• 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: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: CDC-42703-XP1A
• Device Lot Number: 23F15D0929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2015
• 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