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

Model Number SIP-3000

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 08/07/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis of the reported device is anticipated but has not yet begun.A supplemental report will be submitted when the device analysis is completed.(b)(4).

Event Description

The power cord of the orbital atherectomy device (oad) would not stay seated in the stealth saline infusion pump during a peripheral atherectomy procedure.The oad continuously slowed down and turned off.The procedure was successfully completed using another pump, and the patient was well.The procedure was delayed by 40 minutes.

Manufacturer Narrative

The device was received for analysis.Analysis identified the average retention force measurement for the oad power jack was below the specified requirement.As the oad was not returned for analysis, it could not be determined if it was damaged or contributed to the reported difficulties experienced.At the conclusion of the failure analysis investigation the reported event was 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.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 7843247
• MDR Text Key: 119112974
• Report Number: 3004742232-2018-00272
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K133399
• 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: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SIP-3000
• Device Catalogue Number: 70057-03
• Device Lot Number: 228791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Date Manufacturer Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 109