MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY

Model Number 3520

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/10/2023

Event Type  malfunction  

Event Description

It was reported that foreign material is present within the sealed packaging.During preparation of a rotawire and wireclip torquer device, white foreign material was observed within the sealed device package.The device was not used in the procedure and the procedure was completed with another rotawire and wireclip torquer device.No patient harm resulted in relation to this event.

Manufacturer Narrative

Device evaluation by manufacturer: unit returned, and the device observed entanglement.A photo was also provided by the customer, it can be observed part of the guidewire inside the pouch with an unknown white material inside.

Event Description

It was reported that foreign material is present within the sealed packaging.During preparation of a rotawire and wireclip torquer device, white foreign material was observed within the sealed device package.The device was not used in the procedure and the procedure was completed with another rotawire and wireclip torquer device.No patient harm resulted in relation to this event.

Event Description

It was reported that foreign material is present within the sealed packaging.During preparation of a rotawire and wireclip torquer device, white foreign material was observed within the sealed device package.The device was not used in the procedure and the procedure was completed with another rotawire and wireclip torquer device.No patient harm resulted in relation to this event.

Manufacturer Narrative

Device evaluated by manufacturer.The device was observed entanglement.Regarding the media provided by the physician, it can be observed part of the guidewire inside the pouch with an unknown white material inside.

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• 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: jeff wallner johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16234975
• MDR Text Key: 308537558
• Report Number: 2124215-2023-02691
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729185871
• UDI-Public: 08714729185871
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2023

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: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0030337928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 02/14/2023; 03/15/2023
• Supplement Dates FDA Received: 03/13/2023; 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• 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