INTERLOCK?

Report

Report Number: 2134265-2013-05148
Event Type: Injury
Date Received: July 30, 2013
Date of Event: July 1, 2013
Report Date: July 1, 2013
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: KRD
PMA / PMN Number: K060078
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MX
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS AN INCOMPATIBLE CATHETER WAS USED IN THE PROCEDURE. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A JUVENILE NASOPHARYNGEAL ANGIOFIBROMA EMBOLIZATION, THE COIL WAS IMPLANTED IN AN UNINTENDED LOCATION. THE TARGET VESSEL IS LOCATED AT THE EXTERNAL CAROTID. A 2/5MM X 5.8CM VORTX DIAMOND FIBERED INTERLOCK DETACHABLE COIL WAS SELECTED TO TREAT THE TARGET VESSEL. THE COIL WAS ADVANCED THROUGH THE RENEGADE HI FLO MICROCATHETER AND RESISTANCE WAS NOTED. THE LAST PORTION OF THE COIL COULD NOT PASS THE DISTAL MARK OF THE MICROCATHETER. THE PHYSICIAN APPLIED EXTRA FORCE TO DELIVER THE COIL; HOWEVER, THE COIL WAS DEFORMED. THE PHYSICIAN DECIDED TO REMOVE THE COIL FROM THE MICROCATHETER. UPON WITHDRAWAL, THE COIL WAS DETACHED IN THE MICROCATHETER. THE PHYSICIAN FLUSHED THE MICROCATHETER TO PUSH THE COIL INTO THE VESSEL, RESULTING IN THE COIL BEING IMPLANTED MORE PROXIMAL THAN EXPECTED. PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
355601	INTERLOCK?	DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION	KRD	BOSTON SCIENTIFIC - CORK	M001361760	15290079

Patients

Seq	Age	Sex	Outcome	Treatment
1	17 YR		Other