MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CV-22854

Device Problem Material Separation (1562)

Patient Problems Air Embolism (1697); No Information (3190)

Event Date 01/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).At present, the device sample is retained by the user facility.Additional information regarding this event and patient condition requested, but not received at the time of this report.

Event Description

A report was received that there was a damaged lumen on the central line snapped half-way down along the tubing.The central line was inserted on (b)(6) 2017 in the right internal jugular vein for the purpose of medication administration and monitoring purposes the facility reported there was a significant injury to patient due to an air embolism and the patient became peri-arrest.The patient was placed on a mechanical ventilator and admitted to intensive care.The patient required inotropic support to maintain cardiac output.The patient remains gravely ill.Diagnosis of the air embolism was confirmed by aspiration of free air from patient's right-sided cardiac circulation, and confirmed on echocardiographic ultrasound evaluation.After the leak was observed, the central line was clamped, removed and entire line and attached drips retained.

Manufacturer Narrative

(b)(4).Additional information received regarding the condition of the patient: the patient was unwell prior to insertion of central line.Patient discharged from critical care and is recovering well on surgical ward.Investigation results: a 4-lumen catheter marked 8.5fr x 16cm on the juncture hub was returned for evaluation.The medial 2 extension line was separated 2.8cm from the juncture hub.Under microscopic examination, it was observed that the ends of the separated extension line had striations in the surface.The edges of the extension line tubing were sharp and did not appear to be torn.A simulation was performed by cutting an extension line of a lab sample with medical scissors and examining the cut end.Microscopic examination revealed striations in the end of the tubing that appeared very similar to the complaint sample.A device history record (dhr) review could not be performed since the lot number was unknown.The instructions for use (ifu) contains a precaution not to use scissors to remove dressing to minimize the risk of cutting the catheter.The appearance of the separated tubing was consistent with being cut by medical scissors and was replicated by a simulation using a lab sample.Based on the complaint sample and the lab simulation, it was determined that operational context caused this event.

Event Description

A report was received that there was a damaged lumen on the central line snapped half-way down along the tubing.The central line was inserted on (b)(6) 2017 in the right internal jugular vein for the purpose of medication administration and monitoring purposes the facility reported there was a significant injury to patient due to an air embolism and the patient became peri-arrest.The patient was placed on a mechanical ventilator and admitted to intensive care.The patient required inotropic support to maintain cardiac output.The patient remains gravely ill.Diagnosis of the air embolism was confirmed by aspiration of free air from patient's right-sided cardiac circulation, and confirmed on echocardiographic ultrasound evaluation.After the leak was observed, the central line was clamped, removed and entire line and attached drips retained.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6349687
• MDR Text Key: 68034409
• Report Number: 3006425876-2017-00057
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CV-22854
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Life Threatening