MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. PORTEX LINE DRAW DRY HEPARIN ARTERIAL BLOOD SAMPLING KITS; BLOOD COLLECTION KIT

Model Number 4043-2

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

Used exact description of event from voluntary medwatch report mw5056356 that was submitted by user facility.Additional manufacturer narrative: customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

Received notice on voluntary event report (mw5056356) regarding an incident.Event description is as follows: this event involved (b)(6) y/o male who was at (b)(6) on (b)(6) 2015 for an interventional radiologic procedure in operating room 5.This pt has a lot standing history of diabetes, peripheral vascular disease, cigarette smoking, coronary artery disease and atrial fibrillation.Pt was taken to the cath lab for an angiogram.This angiogram showed an occluded superficial femoral artery.The interventional radiologist was able to perform an angioplasty and stents were open, but on final angiographic films, a large thrombus was noted in the common femoral artery extending into the deep and superficial femoral arteries.Ultimately, a vascular surgeon was contacted as this appeared to be a surgical lesion.As this surgical procedure began, coagulation parameters were sent as well as an act.The act was actually repeated twice, and the results kept coming back in the 400-500 sec range.The pt had received 12,000 units of heparin in the cath lab, and also received tpa.Due to the multiple episodes of unexplained clotting, difficulty to anticoagulated and keep stents open, the vascular surgeon elected to perform a femoral to above the knee popliteal bypass.Based on further inquiry, it turns out that the initial acts were sent in the wrong syringe which were inappropriately heparinized, giving a falsely elevated reading.The vascular surgeon then asked that the pt receive 5000 units of heparin.Mr.(b)(6) received heparin a number of add'l times throughout the case at appropriate intervals, and acts were checked at appropriate intervals throughout the rest of the case.Diagnosis or reason for sure: syringe used to obtain blood sample for act study.

• Brand Name: PORTEX LINE DRAW DRY HEPARIN ARTERIAL BLOOD SAMPLING KITS
• Type of Device: BLOOD COLLECTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 10 bowman drive; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 10 bowman drive; keene NH 03431
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5226620
• MDR Text Key: 31314166
• Report Number: 2183502-2015-00877
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 4043-2
• Device Catalogue Number: 4043-2
• Device Lot Number: 2973585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR