MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. STEALTH ORBITAL ATHERECTOMY DEVICE; PERIPHERAL ATHERECTOMY DEVICE

Model Number PRD-SC30-125

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Event Description

A stealth orbital atherectomy device (oad) was selected for use in the left peroneal, proximal popliteal, and distal superior femoral arteries.Treatment was delivered to a lesion in the proximal peroneal artery without issue.During pullback to the popliteal area, the device was spun, and the wire seemed to arc.Tension was observed, and the crown jumped and stopped spinning.The oad crown was now distal to the lesion, and it was re-positioned without spinning.When the device was turned on for distal-to-proximal treatment, it spun momentarily but stopped spinning again.The oad was then retracted in order to remove it from the patient.Tension was again observed.While still not spinning, the oad jumped back into the sheath.When the oad was removed from the patient, the driveshaft was unraveled, and the oad was still on the guide wire.The oad was removed in one single piece and not in separate pieces.Angioplasty and stent placement were performed without issue.After inspecting the damage, the physician categorized the damage as a fracture.

Manufacturer Narrative

(b)(4).Failure analysis conclusion: the device was received at csi for analysis.The saline sheath was damaged and separated in two locations.There were driveshaft filar indentations within the sheath wall inside the separated piece.The driveshaft filars were damaged and deformed, and some filars were fractured.The guide wire section could not be removed from the damaged driveshaft section without further damaging the driveshaft.This section was removed and sent for scanning electron microscopy (sem).The sem analysis of the fractured filar faces revealed fatigue striations.It is possible the saline sheath and driveshaft filar damage and fractures may be the result of localized, elevated stress levels applied to the saline sheath and driveshaft while spinning.Bench testing has recreated similar sheath and shaft damage by compressing the sheath onto the driveshaft with force using an adjustable touhy valve while the driveshaft was spinning.This can cause enough force to result in saline sheath melting, separation, and driveshaft filar fractures.The exact root cause of the sheath and shaft damage could not be 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).

• Brand Name: STEALTH ORBITAL ATHERECTOMY DEVICE
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 9364302
• MDR Text Key: 207947111
• Report Number: 3004742232-2019-00307
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005039
• UDI-Public: (01)10852528005039(17)211231(10)250193
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 70056-03
• Device Lot Number: 250193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 95