MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY

Model Number 3243

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Output Problem (3005); Intermittent Loss of Power (4016)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that difficulty removing and burr detachment occurred.The severely stenosed target lesion was severely calcified.A 1.50mm rotapro and a rotawire were selected for use.During the second run, the system stalled.The rotation was unable to be restarted and difficulty removing the burr occurred.Several attempts were made to remove the burr and the wire; however the burr and the wire broke.The burr was removed with a snare and the broken piece of the wire was jailed with a stent.The patient's status was stable and there were no patient complications reported.

Event Description

It was reported that difficulty removing and burr detachment occurred.The severely stenosed target lesion was severely calcified.A 1.50mm rotapro and a rotawire were selected for use.During the second run, the system stalled.The rotation was unable to be restarted and difficulty removing the burr occurred.Several attempts were made to remove the burr and the wire; however the burr and the wire broke.The burr was removed with a snare and the broken piece of the wire was jailed with a stent.The patient's status was stable and there were no patient complications reported.

Manufacturer Narrative

E1: initial reporter fax: (b)(6).Evaluation conclusion codes: corrected from cmc - adverse event related to patient condition to cause not established.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10714004
• MDR Text Key: 212370404
• Report Number: 2134265-2020-14332
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0025681672
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/21/2020
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 09/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention