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

Model Number DBEC-125

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/17/2019

Event Type  malfunction  

Event Description

During the patient's cardiac catheterization a 24mm segment of the guidewire broke into the patient's vessel.Fragment of guidewire unable to be retrieved at the time of the original procedure, plan to attempt retrieval in future.Experienced physician utilizing the device at the time of the malfunction, has used this product many times without difficulty, was not attempting any unique manipulation of the device.

• Brand Name: DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 8831745
• MDR Text Key: 152373832
• Report Number: 8831745
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)210331(10)262455
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 262455
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/17/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Weight: 102