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

Model Number VPR-GW-FT18

Device Problems Device Misassembled During Manufacturing /Shipping (2912); Compatibility Problem (2960); Incorrect Device Or Component Shipped (2962)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

The guide wire was discarded by the facility and an exact root cause could not be determined.The lot number was initially unknown, but an internal review for this customer identified that the previous two orders of 0.018" flextip guide wires were lot number 156032.A review of lot number 156032 identified that a recall had been initiated for an incorrectly packaged 0.014" flextip guide wire in an 0.018" flextip guide wire package.This is the same issue as mdr 3004742232-2017-00034.(b)(4).

Event Description

It was reported that during a peripheral orbital atherectomy procedure, an abbott nav6 embolic protection device slid off the end of a csi 0.018" viperwire guide wire when removing it from the patient.The physician successfully completed atherectomy, but it was noted that the distal tip of the oad was being brought into contact with the filter during treatment.When the physician attempted to retrieve the filter with the guide wire, he was unsuccessful.The viperwire guide wire was removed from the patient and the physician was then able to retrieve the filter with a snare device.The patient status remained stable throughout the procedure.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: jacob mellem ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 6447444
• MDR Text Key: 71326555
• Report Number: 3004742232-2017-00035
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005329
• UDI-Public: (01)10852528005329(17)180228(10)156032
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/28/2018
• Device Model Number: VPR-GW-FT18
• Device Catalogue Number: VPR-GW-FT18
• Device Lot Number: 156032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2016
• 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): Other