V-14? CONTROLWIRE®

Report

Report Number: 2134265-2014-03932
Event Type: Injury
Date Received: July 10, 2014
Date of Event: June 6, 2014
Report Date: June 11, 2014
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
Product Code: DQX
PMA / PMN Number: K112745
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE GUIDE WIRE FRACTURED. A V-14 LONG TAPER 300CM ANGLED TIP GUIDEWIRE WAS BEING USED BELOW THE KNEE FOR OCCLUSIVE DISEASE, THE TIP FRACTURED AND WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE GUIDE WIRE FRACTURED. A V-14 LONG TAPER 300CM ANGLED TIP GUIDEWIRE WAS BEING USED BELOW THE KNEE FOR OCCLUSIVE DISEASE, THE TIP FRACTURED AND WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
404389	V-14? CONTROLWIRE®	WIRE, GUIDE, CATHETER	DQX	BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)	H74939216930020	16205353

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other