FDA Adverse Event Malfunction Summary report: N

PRELUDE SHEATH INTRODUCERS

MDR report key: 1931187 · Received November 11, 2010

Report

Report Number: 1721504-2010-00376
Event Type: Malfunction
Date Received: November 11, 2010
Date of Event: October 20, 2010
Report Date: October 20, 2010
Manufacturer: MERIT MEDICAL SYSTEMS, INC.
Product Code: DRE
PMA / PMN Number: K070159
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVAL: ONE USED DEVICE WAS RECEIVED FOR EVAL/INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE DEVICE WAS VISUALLY EXAMINED AND THE COMPLAINT WAS CONFIRMED. THE DEVICE WAS EXAMINED USING X-RAY AND FOUND THE SHEATH WAS NOT FULLY INSERTED INTO THE FIXTURE WHEN THE HUB WAS FORMED. SAMPLES FROM INVENTORY WERE TESTED TO DETERMINE IF THIS WAS AN ISOLATED INCIDENT. ALL TEST DEVICES PASSED TESTING. THE ROOT CAUSE FOR THE FAILURE IS ATTRIBUTED TO THE TUBING NOT SEATED FULLY IN THE FIXTURE WHEN THE HUB WAS MOLDED ONTO THE SHEATH. COMPLAINT DATA WILL CONTINUE TO BE MONITORED FOR THIS TYPE OF FAILURE. EVAL: METHOD: THE DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATABASE WAS REVIEWED, X-RAY EXAMINATION.

Description of Event or Problem · 1

THE PHYSICIAN NOTICED AFTER INJECTION THAT THERE WAS A LEAK AT THE HUB. THE SHEATH TUBING WAS NOT COMPLETELY ATTACHED TO THE HUB. THE SHEATH WAS REMOVED WITHOUT INCIDENT. NO HARM OR INJURY REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PRELUDE SHEATH INTRODUCERS	DILATOR, VESSEL, FOR PERCUTANEOUS	DRE	MERIT MEDICAL SYSTEMS, INC.		H157510

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	CONTRAST MEDIA