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

Model Number 3520

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 08/12/2020

Event Type  Injury  

Event Description

It was reported that the wire separated inside the patient, requiring additional surgical intervention, and the procedure was aborted.A 1.50mm rotapro catheter, a 330cm rotawire guidewire, and a guidezila ii guide extension catheter were selected for use in a percutaneous coronary intervention (pci) procedure of the distal right coronary artery (rca).The anatomy was severely tortuous and severely calcified with 75% stenosis.The guidezilla ii failed to cross the lesion.After performing eight ablations with the rotapro in the rca, the system ran out of gas.The gas tank was replaced with a new one.Upon starting ablation again, the rotawire was noted to be fractured at approximately 15cm proximal to the distal tip.The wire loop was suspected, but it was not observed on the angiography.Snaring, entwining, and twisting the wire were done in an attempt to remove the device fragment.The entire device fragment was retrieved through surgical intervention.The rotawire never became stuck on the burr, and the cause of the rotawire fracture is unknown.The procedure was not completed due to this event.The patient was stable post-procedure and post-surgery.

Manufacturer Narrative

Device eval by manufacturer: unit returned in a bio-hazard plastic bag with the related rotablator plus device.The distal portion of the wire was received still inside of the rotablator plus device.The rotawire was unable to be removed from the device.The wire is separated into two pieces.There are numerous kinks along the wire.The distal portion of the wire was received in a separate bag.The proximal separated end was stuck in the rotablator burr catheter and had numerous kinks along the body of the rotawire with 176cm coming out of the burr handshake connection.The wire is separated 14cm from the tip.The distal end of the separation was angled indicating the wire came in contact with the burr.The overall length could not be measured as a portion of the wire was stuck in the burr catheter.The outer diameters of the distal tip, the middle of the device, and the proximal section were all measured and within specifications.

Event Description

It was reported that the wire separated inside the patient, requiring additional surgical intervention, and the procedure was aborted.A 1.50mm rotapro catheter, a 330cm rotawire guidewire, and a guidezila ii guide extension catheter were selected for use in a percutaneous coronary intervention (pci) procedure of the distal right coronary artery (rca).The anatomy was severely tortuous and severely calcified with 75% stenosis.The guidezilla ii failed to cross the lesion.After performing eight ablations with the rotapro in the rca, the system ran out of gas.The gas tank was replaced with a new one.Upon starting ablation again, the rotawire was noted to be fractured at approximately 15cm proximal to the distal tip.The wire loop was suspected, but it was not observed on the angiography.Snaring, entwining, and twisting the wire were done in an attempt to remove the device fragment.The entire device fragment was retrieved through surgical intervention.The rotawire never became stuck on the burr, and the cause of the rotawire fracture is unknown.The procedure was not completed due to this event.The patient was stable post-procedure and post-surgery.

• 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
• MDR Report Key: 10483455
• MDR Text Key: 205320732
• Report Number: 2134265-2020-12179
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729195566
• UDI-Public: 08714729195566
• 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: 11/11/2020

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 Expiration Date: 02/10/2022
• Device Model Number: 3520
• Device Catalogue Number: 3520
• Device Lot Number: 0025194197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention