MAUDE Adverse Event Report: BOSTON SCIENTIFIC; ROTAWIRE AND WIRECLIP TORQUER

Model Number CE0344

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/23/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, patient underwent cardiac catheterization, selective coronary angiography, rotational atherectomy of the l anterior descending artery and percutaneous coronary intervention of the l anterior descending artery with xience 3.0 x 32 mm stent and rotational atherectomy and percutaneous coronary intervention of the ramus intermediau with a 2.5 x 15mm xience alpine stent.Rotational atherectomy was performed using 1.5mm burr and the burr would not pass across the entire lesion, but would lodge at the lesion and this was then removed and the rota-floppy wire was noted to be fractured leaving the distal portion of the rota-floppy in the coronary artery.Attempts to retrieve this were unsuccessful.Boston scientific rotawire and wireclip torquer 0.009in x 330cm guidewire and guidewire manipulation device for rotablator rotational atherectomy system.(b)(4).

• Type of Device: ROTAWIRE AND WIRECLIP TORQUER
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 5285495
• MDR Text Key: 33275897
• Report Number: MW5058427
• Device Sequence Number: 1
• Product Code: MCX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/07/2015

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: 07/07/2017
• Device Model Number: CE0344
• Device Catalogue Number: H8022282400202017-07-27
• Device Lot Number: 18240452
• Other Device ID Number: 0108714729185871(17)170727(10)
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR