DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

Report

Report Number: 3004742232-2013-00002
Event Type: Injury
Date Received: January 14, 2013
Date of Event: December 21, 2012
Report Date: December 21, 2012
Manufacturer: CARDIOVASCULAR SYSTEMS INCORPORATED
Product Code: MCW
PMA / PMN Number: K071427
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT YET BEEN RECEIVED FOR ANALYSIS. WHEN IT IS RETURNED, A SUPPLEMENTAL REPORT WILL BE CREATED WITH THE FAILURE ANALYSIS FINDINGS. THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNKNOWN. (B)(4). DEVICE NOT RETURNED FOR ANALYSIS.

Additional Manufacturer Narrative · 1

DEVICE ANALYSIS: THE OAD WAS RECEIVED WITH THE ORIGINAL GUIDE WIRE ENGAGED IN THE DEVICE. THE INITIAL VISUAL AND TACTILE EXAMINATION OF THE HANDLE ASSEMBLY, SALINE SHEATH AND DRIVESHAFT DID NOT REVEAL ANY DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT; THE CROWN AND DISTAL TIP BUSHING REMAINED INTACT AND UNDAMAGED. BIOLOGICAL MATERIAL WAS OBSERVED ON THE DRIVESHAFT AND THE DISTAL AND PROXIMAL EDGES OF THE CROWN. THE OD OF THE CROWN WAS MEASURED AND MET SPECIFICATION. NO OTHER DAMAGE OR ABNORMALITIES WERE NOTED WITH THE DEVICE OR ITS COMPONENTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. EXAMINATION OF THE EXPOSED PROXIMAL SECTION OF THE GUIDE WIRE DID NOT REVEAL ANY DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE GUIDE WIRE SPRING TIP WAS LODGED WITHIN THE DRIVESHAFT TIP BUSHING AREA. EXAMINATION OF THE GUIDE WIRE REVEALED BIOLOGICAL MATERIAL ADHERED ONTO THE SPRING TIP COILS. SEM ANALYSIS OF THE SPRING TIP COIL REVEALED A FRACTURED SPRING TIP COIL. DAMAGE OF THIS NATURE IS CONSISTENT WITH THE DAMAGE OBSERVED ON A GUIDE WIRE AFTER THE DRIVESHAFT HAS BEEN SPUN CLOSE TO THE GUIDE WIRE SPRING TIP RESULTING IN THE FRACTURE; HOWEVER, THE EXACT CAUSE OF THE FRACTURE OF THE RETURNED GUIDE WIRE IS UNKNOWN. THE PROXIMAL SOLDER BOND REMAINED INTACT AND EXHIBITED DAMAGE CONSISTENT WITH COMING INTO CONTACT WITH THE DRIVESHAFT TIP BUSHING. THE SPRING TIP AND SOLDER BOND MATERIAL WAS SENT FOR SEM ANALYSIS ALONG WITH THE DRIVESHAFT TIP BUSHING. EXAMINATION OF THE REMAINING GUIDE WIRE DID NOT REVEAL ANY DAMAGE OR ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE MATERIAL INSPECTION RECORD FOR THIS GUIDE WIRE COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. AT THE CONCLUSION OF THE FAILURE ANALYSIS INVESTIGATION THE COMPLAINT OF "DEVICE BECAME STUCK ON THE WIRE" WAS CONFIRMED. THE BIOLOGICAL MATERIAL WAS STUCK TO THE GUIDE WIRE AND DRIVESHAFT CAUSING THEM TO BECOME SEIZED. IN ADDITION, THE GUIDE WIRE SPRING TIP SOLDER BOND WAS FOUND TO BE LODGED WITHIN THE DISTAL TIP BUSHING OF THE OAD. SEM ANALYSIS SHOWED LONGITUDINAL DRAG MARKS IN THE SOLDER BOND AND SPRING TIP COILS INDICATING THAT THE TIP BUSHING AND SPRING TIP WERE BROUGHT INTO CONTACT WITH EACH OTHER WHILE NOT SPINNING. NO ISSUES WERE IDENTIFIED ON THE OAD OR GUIDE WIRE THAT WOULD HAVE CAUSED THE BIOLOGICAL MATERIAL ACCUMULATION; THEREFORE, THE EXACT CAUSE OF THE BIOLOGICAL MATERIAL ACCUMULATION COULD NOT BE DETERMINED. THE ROOT CAUSE OF THE REPORTED DISSECTION EVENT REQUIRING STENT PLACEMENT CANNOT BE CONFIRMED. (B)(4).

Description of Event or Problem · 1

NO ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED AND WAS REPAIRED WITH A STENT. THE LESION BEING TREATED WAS LOCATED IN THE 3+CM DIAMETER POSTERIOR TIBIAL (PT) ARTERY. IT WAS HEAVILY CALCIFIED WITH DIFFUSE DISEASE EXTENDING 12CM IN LENGTH AND DEMONSTRATING 50%-100% STENOSIS. THE PHYSICIAN USED A .014 ASTATO 20 GUIDE WIRE, A .014 QUICK CROSS CATHETER, AND A 6F INTRODUCER SHEATH TO ACCESS THE LESION FROM A CONTRALATERAL APPROACH. THE CROWN WOULD NOT ADVANCE THROUGH THE PROXIMAL PT, SO HE SPUN TWICE AT LOW SPEED IN ORDER TO ADVANCE THE CROWN TO THE DISTAL LESION. AFTER SECOND LOW SPEED SPIN, THE CROWN HAD ADVANCED ABOUT 5CMS. THE PHYSICIAN PULLED THE OAS BACK A FEW CENTIMETERS AND THEN STARTED ANOTHER RUN AT LOW SPEED, BUT WAS UNABLE TO ADVANCE THE CROWN. HE ATTEMPTED TO REMOVE THE CATHETER, BUT THE WIRE WAS COMING BACK WITH IT, SO THE ENTIRE OAS WAS REMOVED AS A UNIT. A VESSEL DISSECTION WAS NOTED AND WAS REPAIRED WITH A SUPERA STENT. THE DISTAL LESION WAS TREATED VIA ANGIOPLASTY ONLY. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
21038	DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM	ORBITAL ATHERECTOMY SYSTEM	MCW	CARDIOVASCULAR SYSTEMS INCORPORATED	PRD-SC30-125	60768

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention