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

Model Number 39467-200

Device Problems Contamination (1120); Unsealed Device Packaging (1444)

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

Event Date 03/04/2021

Event Type  malfunction  

Event Description

It was reported that the sterility of the device was compromised.Upon arrival, the packaging seal was noted to be torn on a 2.00mm rotapro.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy system inside the shelf box.The shelf box, closure strip, and product pouch were visually examined.The shelf box, closure strip, and product pouch were visually examined.Inspection of the device revealed that the closure strip on the top of the shelf box was cut.The rotapro device was inside the shelf box in the sealed product pouch.

Event Description

It was reported that the sterility of the device was compromised.Upon arrival, the packaging seal was noted to be torn on a 2.00mm rotapro.No patient complications were reported.

• 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: 11586997
• MDR Text Key: 242980283
• Report Number: 2134265-2021-03974
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2022
• Device Model Number: 39467-200
• Device Catalogue Number: 39467-200
• Device Lot Number: 0026033310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Date Manufacturer Received: 05/12/2021
• Patient Sequence Number: 1