MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number	DBP-125MICRO145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device analysis: the oad was returned with the original guide wire engaged in the device.The initial visual and tactile examination revealed that the driveshaft filars were stretched and elongated at the proximal edge of the crown, extending proximally.Further examination revealed that the crown and distal tip bushing remained intact and undamaged.Biological material was observed on the driveshaft, crown and embedded within the driveshaft at the location of the crown.Examination in the area of the material did not reveal any damage that would have contributed to the accumulation.The outside diameter (od) of the crown was measured using a calibrated dial caliper and met the drawing specification.The initial visual and tactile examination of the exposed sections of the guide wire revealed bends and kinks in the distal shaft section.Further examination revealed that the spring tip remained intact and undamaged.Biological material was observed on the proximal spring tip coils and on the shaft just proximal to the proximal spring tip solder bond.Examination in the areas of the adhered material did not reveal any damage that would have contributed to the accumulation.The guide wire could not be removed from the driveshaft.This section was destructively removed to allow for the removal of the remaining section of the guide wire.Examination of the remaining section of the guide wire revealed additional kinks.An in-house test wire was loaded through the destructively cut section of the driveshaft and handle assembly without issue.When tested, the device spun at low, medium and at high speed with no abnormalities observed.The device and components functioned as intended with no abnormalities observed.At the conclusion of the failure analysis investigation, the root cause of the dissection could not 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 and components met material, assembly, and quality control requirements.The material inspection report for the guide wire was not reviewed as the lot number is unknown.(b)(4).
Event or Problem Description
It was reported that during a peripheral orbital atherectomy procedure, a type d dissection occurred while using a csi orbital atherectomy device (oad).The target lesion was located in the anterior tibial (at) artery.The physician used a 5fr introducer sheath and a v18 crossing guide wire to access the lesion.The v18 guide wire was exchanged for a csi viperwire guide wire and the oad was loaded onto it.The physician performed one run at low speed and one run at medium speed in the at artery.Post-atherectomy angiography revealed a type d dissection in the at artery.A 2.5mm x 60mm balloon was inflated across the dissection for three minutes and resolved it.The patient status remained stable throughout the procedure.Additional information has been requested, but none has yet been received.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 6198512
• Report Number: 3004742232-2016-00148
• Device Sequence Number: 16322846
• Product Code: MCW
• UDI-Device Identifier: 10852528005190
• UDI-Public: (01)10852528005190(17)170531(10)127737
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2016

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?: No
• Operator of Device: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 127737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2016
• Initial Report FDA Received Date: 12/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other