FDA Adverse Event Malfunction Summary report: N

MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

MDR report key: 6344647 · Received February 21, 2017

Report

Report Number: 3002808486-2017-00520
Event Type: Malfunction
Date Received: February 21, 2017
Date of Event: April 5, 2013
Report Date: April 5, 2013
Manufacturer: WILLIAM COOK EUROPE
Product Code: KRD
UDI-DI: 00827002202320
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). PMA 510(K): SIMILAR TO DEVICE UNDER 510(K): K063619. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: USED TDS RETURNED TO AID THE INVESTIGATION. EXAMINATION OF TDS DELIVERY WIRE FOUND THREAD INTACT AND MANUFACTURED ACCORDING TO SPECIFICATIONS. IT IS PLAUSIBLE THAT THE COIL WAS PREMATURELY RELEASED DUE TO UNINTENTIONALLY ROTATION OF THE DELIVERY WIRE DURING PLACEMENT OF THE COIL, OR TOO LARGE A GAP BETWEEN THE THREAD OF THE DELIVERY WIRE AND THE COIL DURING LOADING PROCEDURE. HOWEVER, COIL WAS NOT RETURNED AND WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE OF THIS EVENT. 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: COIL HAS PREMATURELY DETACHED ITSELF FROM THE SUPPORT SYSTEM, COIL GOT DETACHED BEFORE IT WAS PLACED. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
128032	MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL	KRD DEVICE, EMBOLIZATION, VASCULAR	KRD	WILLIAM COOK EUROPE			00827002202320

Patients

Seq	Age	Sex	Outcome	Treatment
1