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

Model Number DBEC-125

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.Analysis identified the presence of foreign material embedded within the driveshaft located 108cm from the distal tip bushing.The material prevented guide wire passage.The origin of the observed material is under investigation.Abbott will submit a supplemental report once the investigation is complete.Csi id: (b)(4).

Event Description

A diamondback 360 coronary orbital atherectomy device (oad) was used to perform two low-speed treatments each of 3 areas in a 90% stenosed, slightly calcified, 270-degree or more-calcium arc, 1.5mm-in-diameter lesion in the left anterior descending (lad) mid artery via transradial intervention (tri) using intravascular ultrasound (ivus).The oad was loaded over a viperwire advance coronary guide wire to perform a high-speed treatment next, but the viperwire could not pass through the back end of the oad handle.Moving the guide wire brake lever and the crown advancer knob did not resolve the issue.The oad was replaced to complete the procedure.The patient was stable.The oad which did not allow for viperwire passage was returned to abbott for analysis which identified the presence of material within the driveshaft.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19084010
• MDR Text Key: 340681528
• Report Number: 3004742232-2024-00162
• Device Sequence Number: 1
• Product Code: MCX
• 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,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2024

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: Health Professional
• Device Model Number: DBEC-125
• Device Lot Number: 442540-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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 Sex: Male