FDA Adverse Event Injury Summary report: N

PIU2 C7XR

MDR report key: 9571724 · Received January 9, 2020

Report

Report Number: 3009600098-2019-00032
Event Type: Injury
Date Received: January 9, 2020
Date of Event: December 9, 2019
Report Date: March 20, 2020
Manufacturer: ST. JUDE MEDICAL CATD
Product Code: NQQ
PMA / PMN Number: K111201
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

ONE C7XR PIU WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. PRODUCT TESTING REVEALED THE PIU FORJ WAS THE CAUSE OF THE CONNECTION ISSUE. THE UNIT WAS MANUFACTURED ON 18FEB12 AND BEING USED BEYOND ITS TWO-YEAR LIFE EXPECTANCY, THE ROOT CAUSE OF FAULTY FORJ WAS DETERMINED TO BE NORMAL WEAR AND TEAR. DEVICE HISTORY RECORD (DHR) REVIEW OF DOC PIU SN: (B)(4) FOUND NO EXCURSIONS FOR MANUFACTURING ISSUES WITH THE COMPLAINT DOC PIU. AT THE TIME OF MANUFACTURED, TESTING OF THE COMPLAINT, PIU EXHIBITED 100% PASS RESULTS. IN SUMMARY, ALL DOCUMENTS IN THE DHR, INCLUDING DATASHEETS, PRINTOUTS AND TEST RESULTS, WERE COMPLETED AND PRESENT PER GOOD DOCUMENTATION PRACTICES AND ALL RESULTS WERE WITHIN SPECIFICATIONS, THEREFOR, THE ISSUE IS NOT A MANUFACTURING OR DESIGN RELATED AND NO CAPA IS REQUIRED.

Description of Event or Problem · 1

MANUFACTURING RELATED REF: 3008452825-2019-00642, 3008452825-2019-00643. WHEN ATTEMPTING OCT WITH THE FIRST CATHETER, THE MONITOR SHOWED A CONNECTION ISSUE. A SECOND CATHETER WAS USED BUT THE ISSUE PERSISTED. THE DOC WAS NOT WORKING. THE PROCEDURE WAS NOT ABLE TO BE COMPLETE AND WAS RESCHEDULED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
33964	PIU2 C7XR	SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)	NQQ	ST. JUDE MEDICAL CATD	12642-08	3581260

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER\| DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER