FDA Adverse Event Injury Summary report: N

OPTOWIRE DEUX

MDR report key: 6053455 · Received October 25, 2016

Report

Report Number: 3008061490-2016-00001
Event Type: Injury
Date Received: October 25, 2016
Date of Event: September 28, 2016
Report Date: September 30, 2016
Manufacturer: OPSENS INC.
Product Code: DXO
PMA / PMN Number: K152991
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT EVALUATION: INVESTIGATION OF THE DEVICE COULD NOT BE PERFORMED BECAUSE IT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICE MET ALL VISUAL, DIMENSIONAL, AND FUNCTIONAL SPECIFICATIONS AT THE TIME IT WAS MANUFACTURED, PRIOR TO SHIPMENT. THERE WAS NO EVIDENCE TO SUGGEST THERE WAS AN INTRINSIC DEFECT IN THE PRESSUREWIRE AND THE CAUSE FOR THE REPORTED EVENT REMAINS UNKNOWN. THE PRESSUREWIRE INSTRUCTIONS FOR USE (IFU) STATES THAT VESSEL DISSECTION IS A POTENTIAL COMPLICATION WHICH MAY BE ENCOUNTERED DURING CORONARY ANGIOGRAPHY AND CORONARY ANGIOPLASTIES. THE PRESSUREWIRE INSTRUCTIONS FOR USE (IFU) STATES THAT THE USER SHOULD NOT TORQUE THE PRESSUREWIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP; OTHERWISE VESSEL TRAUMA MAY OCCUR. DEVICE NOT RETURNED FOR INVESTIGATION.

Description of Event or Problem · 1

WHILE PERFORMING A FFR PROCEDURE ON A PATIENT WITH ANGINA PECTORIS, A CORONARY DISSECTION OCCURED WHEN THE PHYSICIAN TRIED TO DELIVER THE OPTOWIRE PRESSURE GUIDEWIRE IN LAD. NO CALCIFICATION OR TORTUOUSNESS WERE NOTED. THE DISSECTION WAS TREATED WITH A PCI PROCEDURE. THE PROCEDURE WAS COMPLETED. THE PATIENT IS IN A STABLE CONDITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
704346	OPTOWIRE DEUX	PRESSURE GUIDEWIRE	DXO	OPSENS INC.	F1014	OW-0211D

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention