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

Model Number 2077-02

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.

Event Description

It was reported that the packaging seal was compromised.A rotawire drive device inner plastic pouch was found opened and the outer box of package seal peeled off.There was no visible tear or hole in the inner package.There was no patient involved.

Event Description

It was reported that the packaging seal was compromised.A rotawire drive device inner plastic pouch was found opened and the outer box of package seal peeled off.There was no visible tear or hole in the inner package.There was no patient involved.

Manufacturer Narrative

Device evaluated by manufacturer: a visual examination revealed that the pouch of the device was noted opened and damaged.There was no visual damages were noticed within the guidewire.Microscope inspection showed that the pouch and the seals had been attached.Inspection of the remainder of the device presented no other damage or irregularities.B3: date of event: the event date was note reported.The first date of the month of the aware date was entered as an estimate.

• Brand Name: ROTAWIRE DRIVE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13891460
• MDR Text Key: 287908189
• Report Number: 2134265-2022-03342
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

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 Expiration Date: 08/09/2023
• Device Model Number: 2077-02
• Device Catalogue Number: 2077-02
• Device Lot Number: 0027806091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 06/01/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2021
• 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