FDA Adverse Event Malfunction Summary report: N

FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM

MDR report key: 6360042 · Received February 27, 2017

Report

Report Number: 3002808486-2017-00663
Event Type: Malfunction
Date Received: February 27, 2017
Date of Event: September 11, 2015
Report Date: September 11, 2015
Manufacturer: WILLIAM COOK EUROPE
Product Code: KRD
UDI-DI: 00827002200265
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SIMILAR TO DEVICE UNDER 510(K) K063619. SUMMARY OF INVESTIGATIONAL FINDINGS: TDS DELIVERY WIRE ((B)(4)) AND IMWCE COIL ((B)(4)) RETURNED SEPARATELY FOR INVESTIGATION. INSPECTION OF DEVICES FOUND NO ISSUES. PERFORMANCE TEST WAS MADE BY CONNECTING THE COIL TO THE DELIVERY WIRE AND SIMULATING DETACHMENT, NO ISSUES FOUND. BASED ON INVESTIGATION OF RETURNED PRODUCTS, IT IS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE FOR THE EVENT, BUT PLAUSIBLY THE "UNABLE TO RELEASE COIL" OCCURRED DUE TO NOT TURNING THE PIN VISE COUNTERCLOCKWISE TO DETACH THE DELIVERY WIRE FROM THE COIL AND/OR TO THE PIN VISE NOT BEING PROPERLY LOCKED TO THE PROXIMAL END OF THE DELIVERY WIRE AS SPECIFIED IN THE IFU. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

Description of Event or Problem · 1

DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: SINCE THE COIL WOULD NOT BE DETACHED FROM THE DELIVERY SYSTEM, THESE TWO DEVICES WERE REMOVED FROM THE PATIENT AS A UNIT. THEN, OTHER DEVICES WERE USED INSTEAD. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
145675	FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM	KRD DEVICE, EMBOLIZATION, VASCULAR	KRD	WILLIAM COOK EUROPE			00827002200265

Patients

Seq	Age	Sex	Outcome	Treatment
1