DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
Report
- Report Number
- 3004742232-2020-00112
- Event Type
- Injury
- Date Received
- April 7, 2020
- Date of Event
- March 6, 2020
- Report Date
- December 23, 2020
- Manufacturer
- CARDIOVASCULAR SYSTEMS, INC.
- Product Code
- MCX
- UDI-DI
- 10852528005794
- PMA / PMN Number
- P130005
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
SHISHIDO, K., TANAKA, Y., SAITO, S. (2020, DECEMBER). SUCCESSFUL RETRIEVAL OF A FRACTURED AND DETACHED CROWN FROM A CORONARY ORBITAL ATHERECTOMY SYSTEM. JACC: CASE REPORTS, 2(15), 2336-2338. DOI:2(15):2336-2338. CSI ID#: (B)(4).
THE REPORTED OAD AND GUIDE WIRE WERE RECEIVED, ENGAGED, FOR ANALYSIS. THE RESULTS OF THE ANALYSIS OF EACH COMPONENT CAN BE FOUND BELOW. OAD: VISUAL EXAMINATION OF THE OAD REVEALED A FRACTURE AT THE PROXIMAL EDGE OF THE CROWN, AND THE FRAGMENT WAS RECEIVED WITH THE OTHER COMPONENTS. THE GUIDE WIRE WAS REMOVED FROM THE OAD AND PASSED THROUGH THE OAD WITH NO RESISTANCE. SCANNING ELECTRON MICROSCOPY IDENTIFIED FATIGUE STRIATIONS ON THE OAD FRACTURE FACES. THEREFORE, IT IS HYPOTHESIZED THAT THIS DRIVESHAFT UNDERWENT EXCESSIVE FLEXING NEAR THE CROWN DUE TO SPINNING IN EXCESSIVE TORTUOSITY OR RESISTANCE THAT PUSHED THE DRIVESHAFT INTO A TIGHT BEND SHAPE, ALTHOUGH THE EXACT ROOT CAUSE OF THE OAD FRACTURE IS UNDETERMINED. THE OAD FUNCTIONED AS INTENDED DURING ANALYSIS. THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM (OAS) INSTRUCTIONS FOR USE STATES, "NEVER FORCE THE CROWN IF ANY RESISTANCE IS FELT WITHIN THE VESSEL AS VESSEL PERFORATION MAY OCCUR. IF RESISTANCE IS FELT, RETRACT THE CROWN, WHILE MONITORING THE CAUSE OF THE RESISTANCE, AND IMMEDIATELY STOP TREATMENT. USE FLUOROSCOPY TO ANALYZE THE SITUATION AND TO MONITOR THE CAUSE OF THE RESISTANCE." AT THE CONCLUSION OF THE DEVICE ANALYSIS, THE REPORTED DRIVESHAFT FRACTURE WAS CONFIRMED. 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 EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. GUIDE WIRE VISUAL EXAMINATION OF THE GUIDE WIRE REVEALED A FRACTURE, AND THE SPRING TIP WAS RECEIVED WITH THE OTHER COMPONENTS. SCANNING ELECTRON MICROSCOPY OF THE GUIDE WIRE REVEALED A KINK AND EVIDENCE OF TENSILE FAILURE. AS THE SITE REPORTED THAT THE GUIDE WIRE WAS NOT FRACTURED PRIOR TO RETURNING THE DEVICE, THE CAUSE OF THE GUIDE WIRE FRACTURE IS UNKNOWN AND IS NOT CONSIDERED A CONTRIBUTING FACTOR IN THE EVENT. THE MATERIAL INSPECTION REPORT FOR THE REPORTED GUIDE WIRE WAS UNABLE TO BE REVIEWED, AS THE LOT NUMBER WAS NOT PROVIDED. CSI ID#: (B)(4).
THE PROCEDURE WAS COMPLETED WITH CUTTING BALLOON DILATIONS AND STENT PLACEMENT.
THE GUIDE WIRE WAS INTACT UPON REMOVAL FROM THE PATIENT.
ANALYSIS OF THE REPORTED DEVICE IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED. (B)(4).
DURING A PROCEDURE, THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A LESION IN THE HIGHER LATERAL BRANCH OF THE LEFT CIRCUMFLEX ARTERY. THE VESSEL WAS HIGHLY TORTUOUS AND THERE WAS 270 DEGREES OF CALCIFICATION. THE LESION WAS TREATED WITH THREE PASSES IN A DISTAL-TO-PROXIMAL DIRECTION. AFTER TREATMENT, IT WAS OBSERVED THAT THE OAD HAD FRACTURED AT THE PROXIMAL EDGE OF THE CROWN. THE OAD FRAGMENT WAS REMOVED WITH A 4.0 MM SNARE. THE PATIENT CONDITION WAS GOOD FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 396478 | DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM | CORONARY ATHERECTOMY DEVICE | MCX | CARDIOVASCULAR SYSTEMS, INC. | DBEC-125 | 281831 | 10852528005794 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |