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

Model Number 2077-01

Device Problem Unsealed Device Packaging (1444)

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

Event Date 10/15/2021

Event Type  malfunction  

Event Description

It was reported that the package inner seal was compromised.During unpacking the box containing five rotawire drive devices, the inner package seal of one device was compromised.No patient involvement.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotawire drive within the pouch.The pouch was visually inspected, and it was found that a corner of the pouch vendor seal had come apart.Inspection of the seal found that the vendor seal appeared not to have been fully formed.Product analysis confirmed the reported event, as the device was received with the vendor seal compromise.

Event Description

It was reported that the package inner seal was compromised.During unpacking the box containing five rotawire drive devices, the inner package seal of one device was compromised.No patient involvement.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotawire drive within the pouch.The pouch was visually inspected, and it was found that a corner of the pouch vendor seal had come apart.Inspection of the seal found that the vendor seal appeared not to have been fully formed.Product analysis confirmed the reported event, as the device was received with the vendor seal compromise.

Event Description

It was reported that the package inner seal was compromised.During unpacking the box containing five rotawire drive devices, the inner package seal of one device was compromised.No patient involvement.

• 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: 12750996
• MDR Text Key: 280090383
• Report Number: 2134265-2021-13816
• 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,Followup
• Report Date: 12/21/2021

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: 07/20/2023
• Device Model Number: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0027698472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/04/2021
• Supplement Dates Manufacturer Received: 12/14/2021; 12/17/2021
• Supplement Dates FDA Received: 12/16/2021; 12/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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