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

Model Number DBP-125SOLID145

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

The reported oad was received for analysis.Visual examination revealed a gap in the set adhesive for the motor cable.During functional testing a saline solution was poured onto the motor housing, and the speed of the oad was observed to fluctuate as a result of the moisture ingress.All expected led lights were observed to be visibly lit.At the conclusion of the failure analysis investigation, the reported events that the oad sounded as though it were losing speed and the low speed button began blinking were partially confirmed.The motor did not fully stop spinning during analysis, however it spun inconsistently and was unable to maintain speeds.The report that the patient became symptomatic during the procedure occurred prior to the reported device issue.The device analysis was unable to confirm if the device issues experienced could cause or contribute to the patient issues reported.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: 07872.

Event Description

The peripheral diamondback orbital atherectomy device (oad) was operated on all speeds during treatment to the proximal side of the superficial femoral artery (sfa) with no issues observed.The oad was advanced to the distal side of the sfa and the patient presented with hypotension and bradycardia.Administration of pharmacological therapy was performed to stabilize the patient, and the treatment was continued.The oad sounded as though it were losing speed and the low speed button began blinking.Troubleshooting attempts to power the oad on and off were unsuccessful, and a second oad was opened to complete the procedure.The reported issues with the oad occurred after the reported patient adverse event and there is no indication that the two events are related.The patient was reportedly well.Per the opinion of the physician, it was unclear why the patient became symptomatic during the procedure.It was reported that the patient has experienced hypotension in previous procedures.

Manufacturer Narrative

Csi #id: (b)(4).

Event Description

Administration of pharmacological therapy including nitroglycerin, atropine and neosynephrine was performed to stabilize the patient.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 9383875
• MDR Text Key: 168244544
• Report Number: 3004742232-2019-00309
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005244
• UDI-Public: (01)10852528005244(17)210731(10)279384
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: DBP-125SOLID145
• Device Lot Number: 279384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 70