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

Model Number 3520

Device Problem Difficult to Remove (1528)

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

Event Date 03/07/2024

Event Type  Injury  

Event Description

It was reported that guidewire removal difficulty occurred resulting in a procedure cancellation, requiring additional surgery.A rotawire was selected for a percutaneous coronary intervention (pci) procedure.During the procedure, after successfully ending rotablation of the medial and distal right coronary artery (rca), the 1.25mm burr system was removed per dynaglide out of the vessel.When removing the rotawire, a non-bsc guidewire was placed parallel to the rotawire.However, the rotawire stopped in a slide curve of the vessel and could no longer be moved, proximally or distally, and was stuck more proximal where the diameter of the vessel was nearly 3mm.Furthermore, the rotawire was attempted to be removed from the vascular wall by using anon-bsc device, with no success.The procedure was canceled.The patient was stable, however the physician sent the patient to surgery.The rotawire was completely removed from the patient.The patient was stable post-surgery.

Manufacturer Narrative

E1: initial reporter telephone +(b)(4).

• Brand Name: ROTAWIRE AND WIRECLIP TORQUER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18978505
• MDR Text Key: 338597035
• Report Number: 2124215-2024-17930
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/26/2024

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 Model Number: 3520
• Device Catalogue Number: 3520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention