FDA Adverse Event Malfunction Summary report: N

FORMULA 414 RX RENAL BALLOON-EXPANDABLE STENT

MDR report key: 6334889 · Received February 16, 2017

Report

Report Number: 3002808486-2017-00454
Event Type: Malfunction
Date Received: February 16, 2017
Date of Event: February 11, 2016
Report Date: February 26, 2016
Manufacturer: WILLIAM COOK EUROPE
Product Code: NIN
UDI-DI: 10827002455020
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SIMILAR TO DEVICE UNDER 510(K) P100028. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: NO PRODUCT WAS RETURNED AND NO IMAGING WAS PROVIDED, AND BASED ON VERY LIMITED INFORMATION PROVIDED THE EXACT REASON, WHY IT "WAS DIFFICULT TO GO THROUGH WITH THE SECOND STENT" CANNOT BE DETERMINED. AND ALSO, IT IS NOT POSSIBLE TO COMMENT ON THE DISTAL PORTION BEING "CRUSHED AND RELEASED INSIDE THE SHEATH." THERE IS NO EVIDENCE TO SUGGEST PRODUCT 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: THE PATIENT WAS BEING SUBMITTED TO AN ANGIOPLASTY AND AFTER THE CATHETERIZATION OF THE LEFT ARTERY WAS DIFFICULT TO GO THROUGH WITH THE SECOND STENT. MANY ATTEMPTS WERE REALIZED TO GO THROUGH WITHOUT SUCCESS. THEN THE STENT WAS REMOVED AND ITS DISTAL PORTION WAS CRUSHED AND RELEASED INSIDE THE SHEATH. 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
120665	FORMULA 414 RX RENAL BALLOON-EXPANDABLE STENT	WLQ BALLOON STENT	NIN	WILLIAM COOK EUROPE			10827002455020

Patients

Seq	Age	Sex	Outcome	Treatment
1