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

Model Number DBEC-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/18/2021

Event Type  Injury  

Event Description

The patient experienced anaphylactic shock five hours post-atherectomy.The physician suspected the reaction was related to viperslide.The patient was stable the following day after standard treatment for anaphylaxis.

Manufacturer Narrative

Return of the device for analysis is anticipated.After the device is received, it will be forwarded to the manufacturer for analysis, and a supplemental report will be submitted after the device analysis is completed.Csi id: (b)(4).

Manufacturer Narrative

Information was received which indicates the physician has ruled out our product as contributory.The event no longer meets the definition of a reportable event.Csi id: (b)(4).

Event Description

An allergic reaction unrelated to csi product occurred.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 13042750
• MDR Text Key: 282487844
• Report Number: 3004742232-2021-00425
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 30852528005125
• UDI-Public: (01)30852528005125(17)220831(10)10PI5512-1
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: DBEC-125
• Device Lot Number: 10PI5512-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male