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

Model Number DBP-200SOLID145

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Material Separation (1562); Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

The reported oad was received for analysis with the guide wire.The crown driveshaft section of the oad was found to be detached and the guide wire was received with a detached spring tip.The spring tip fragment was not received for analysis and no stent fragments were noted on the returned devices.Scanning electron microscopy (sem) was performed on the driveshaft and found fatigue on multiple filars as well as evidence that filars had been destructively cut.The driveshaft was found to be overloaded at the lap weld, indicating that the device experienced some form of resistance while spinning.This may have been the result of spinning inside a stent, though this could not be confirmed.The sem analysis also found evidence of torsional overload on the fractured guide wire.Target lesions located inside a stent are contraindicated per the peripheral oad ifu.At the conclusion of the device analysis investigation, the reported device detachment was confirmed.However, the root cause of the detachment was unable to be determined.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.The material inspection report for the guide wire was unable to be reviewed, as the lot number was not provided.(b)(4).

Event Description

During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), the device became detached and caught on a stent.The target lesion was located in the iliac and was highly calcified.Following the first pass with the oad, the device became detached and the driveshaft and guide wire became caught in a previously placed stent.One portion of the device was retrieved with a snare, and balloon angioplasty was performed.An additional portion of the detached device along with the remainder of the stent were removed surgically.The patient was discharged the following day in stable condition.

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 7568937
• MDR Text Key: 110069769
• Report Number: 3004742232-2018-00153
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005275
• UDI-Public: (01)10852528005275(17)200131(10)215703
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133399
• 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: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: DBP¿200SOLID145
• Device Lot Number: 215703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention