MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number 3241

Device Problems Fracture (1260); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a wire separation occurred.The 90% stenosed target lesion was located in the proximal left anterior descending artery.A unknown rotablator was selected for use.During the procedure, it was noted that the rotawire got separated approximately 6cm from the tip inside the patient's body.The burr could have contributed to the fracture.The device was retrieved by using a snare.The procedure was completed with a different device.There were no complications reported.

Event Description

It was reported that a wire separation occurred.The 90% stenosed target lesion was located in the proximal left anterior descending artery.A unknown rotablator was selected for use.During the procedure, it was noted that the rotawire got separated approximately 6cm from the tip inside the patient's body.The burr could have contributed to the fracture.The device was retrieved by using a snare.The procedure was completed with a different device.There were no complications reported.It was further reported that there were no fragments left inside the patient's body.A 2.00mm rotablator was used.The wire appeared to have a bend on the detached portion once removed.The patient's condition was good post procedure.

Manufacturer Narrative

(b)(6).

• Brand Name: ROTALINK PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9491231
• MDR Text Key: 176759359
• Report Number: 2134265-2019-15950
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

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: 07/29/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0022579804
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROTAWIRE AND WIRECLIP TORQUER; ROTAWIRE AND WIRECLIP TORQUER