MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. UNKNOWN; SPRING WIRE GUIDE PRODUCTS

Catalog Number VASCULAR UNKNOWN

Device Problem Material Fragmentation (1261)

Patient Problems Death (1802); Embolism (1829); Device Embedded In Tissue or Plaque (3165)

Event Date 11/09/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 03; lot# 23f15c1915.Separate guide wire catalog number was aw-04435; lot# 14f15d0181.Qn#(b)(4).No sample will be returned for evaluation.

Event Description

It was reported the patient was admitted to the emergency room on (b)(6) 2015 with pneumonia and respiratory failure.A central venous catheter was placed in the patient's right femoral vein.There was no indication that the guide wire was not intact at removal.The patient was then sent to the intensive care unit where it was determined that another catheter should be placed because the femoral one was inappropriate.Another central venous catheter was then placed into the patient's right internal jugular with the use of a separate guide wire from a stand-alone wire kit.The femoral cvc was then removed without issue.There was no indication from the inserting clinicians that anything was wrong after insertion.On (b)(6) 2015, the patient received an upper chest ct scan for the respiratory illness.It was then that they observed the patient had roughly 15cm of what appeared to be a fragment of guide wire in the right hepatic vein.The patient was then transferred from corning hospital to (b)(6) hospital in (b)(6).On (b)(6) 2015, a vascular endoscopy under fluoroscopy was performed to attempt removal of the guide wire fragment but was unsuccessful.It was later noted that the patient expired.The vascular surgeon determined that the wire fragment was not the cause, but chronic respiratory failure.

• Brand Name: UNKNOWN
• Type of Device: SPRING WIRE GUIDE 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: 5322558
• MDR Text Key: 34246960
• Report Number: 1036844-2015-00596
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VASCULAR UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: THE CATALOG NUMBER OF THE CVC KITS USED WAS AK-457
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Weight: 102