MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-45703-PPHPB

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

Patient Problem Death (1802)

Event Date 01/01/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).The user facility was contacted (via emails and phone) to obtain additional information regarding the event.The user facility could not confirm if the device caused or contributed to the patient's death.The user facility could not confirm if the patient's preexisting conditions caused or contributed to the patient's death.Note: medwatch (from customer) documents the date of patient death as (b)(6) 2018.Teleflex will use (b)(6) 2018 as date of patient death on the medwatch form.

Event Description

According to the medwatch ((b)(4)) "during a cardiac resuscitation, doctor attempted central line placement in the patient's right femoral vein.When feeding the guidewire, the wire unraveled in the patient.She had difficulty removing from the patient.Patient required another femoral line to be placed in left femoral vein".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

According to the medwatch ((b)(4)) "during a cardiac resuscitation, doctor attempted central line placement in the patient's right femoral vein.When feeding the guidewire, the wire unraveled in the patient.She had difficulty removing from the patient.Patient required another femoral line to be placed in left femoral vein".

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7313873
• MDR Text Key: 101516156
• Report Number: 1036844-2018-00082
• 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: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: ASK-45703-PPHPB
• Device Lot Number: 23F17C0534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2018
• Initial Date FDA Received: 03/05/2018
• Supplement Dates Manufacturer Received: 04/02/2018
• Supplement Dates FDA Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2017
• 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): Death
• Patient Age: 85 YR
• Patient Weight: 138