MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY SYSTEM

Model Number DBEC-125

Device Problems Unintended Movement (3026); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

The reported oad was received for analysis.No damage was visible observed on the oad.A guide wire was passed through the oad with no resistance.The device was tested, spun at all speeds, and functioned as intended.No abnormal noises were heard.At the conclusion of the device analysis, the reported event of the oad being unable to pass through the lesion, making an unusual noise, and retracting the guide wire was unable to be conclusively 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.Csi id# (b)(4).

Event Description

A csi diamondback coronary orbital atherectomy device (oad) was used to treat two lesions in the mid-right coronary artery (rca) and one lesion in the left anterior descending coronary artery (lad).The lesions were all 90% stenosed and severely calcified with a channel running down the center.An initial attempt was made to cross the first rca lesion with a balloon, however, the balloon would not cross.The lesion was then crossed with a microcatheter, and the viperwire guide wire was placed.The oad was unable to completely pass through the first lesion in the rca.Attempts were made 4-5 times with device repositioning, however, the oad was still unable to pass.There was driveshaft compression which caused the wire to retract.The lesion was then ballooned and stented with a good result.The second rca lesion was then ballooned, however, it ballooned in a "dog bone" shape.Attempts were made to treat with the oad, however, the oad was unable to cross the second lesion.No additional treatment was able to be performed on the second rca lesion.The lad lesion was wired, however, the oad was unable to cross the lesion.It was noted that the oad handle was making a ticking noise.The oad was replaced, and the second oad was able to cross and treat the lad lesion with no further issues.The procedure was delayed by two and a half hours due to the treatment issues.It was determined that no additional treatment would be performed on the second rca lesion as the patient was approaching four bars of radiation.The patient was fine following the procedure.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY SYSTEM
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 10194849
• MDR Text Key: 197593014
• Report Number: 3004742232-2020-00178
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)220131(10)305681
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 305681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR