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

Model Number 3241

Device Problems Entrapment of Device (1212); Device Damaged by Another Device (2915); Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 05/14/2021

Event Type  Injury  

Event Description

It was reported that guidewire entrapment occurred and the physician felt pain while holding the sheath.The 90% stenosed target lesion was located in the proximal circumflex artery.A 1.25mm rotalink plus, a 330cm rotawire and wireclip torquer and a rotablator console were selected for use in a percutaneous coronary intervention.The rotawire was successfully advanced with the non-boston scientific support catheter to the target lesion.The rotalink plus was loaded onto the rotawire up to the homeostatic valve outside the patient.An attempt was made to set the revolutions; however, the number of revolutions could not be read on the rotablator console.The rotalink plus was running for seconds.The physician felt a sharp pain on the thumb that was holding the sheath of the rotalink plus burr.Two small holes were observed on the sheath.Difficulty removing the rotalink plus from the rotawire occurred; therefore both devices were removed together as one.The tip of the rotawire was torn off into two short pieces and remain in the distal circumflex artery.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that guidewire entrapment occurred and the physician felt pain while holding the sheath.The 90% stenosed target lesion was located in the proximal circumflex artery.A 1.25mm rotalink plus, a 330cm rotawire and wireclip torquer and a rotablator console were selected for use in a percutaneous coronary intervention.The rotawire was successfully advanced with the non-boston scientific support catheter to the target lesion.The rotalink plus was loaded onto the rotawire up to the homeostatic valve outside the patient.An attempt was made to set the revolutions; however, the number of revolutions could not be read on the rotablator console.The rotalink plus was running for seconds.The physician felt a sharp pain on the thumb that was holding the sheath of the rotalink plus burr.Two small holes were observed on the sheath.Difficulty removing the rotalink plus from the rotawire occurred; therefore both devices were removed together as one.The tip of the rotawire was torn off into two short pieces and remain in the distal circumflex artery.No patient complications were reported and the patient's status was stable.It was further reported that the target lesion in the proximal circumflex was moderately tortuous and severely calcified.The detached rotawire pieces remained in the patient due to the flow of the vessel was good.The patient is scheduled to return at a later date to treat the lesion.

Event Description

It was reported that guidewire entrapment occurred, and the physician felt pain while holding the sheath.The 90% stenosed target lesion was located in the proximal circumflex artery.A 1.25mm rotalink plus, a 330cm rotawire and wireclip torquer and a rotablator console were selected for use in a percutaneous coronary intervention.The rotawire was successfully advanced with the non-boston scientific support catheter to the target lesion.The rotalink plus was loaded onto the rotawire up to the homeostatic valve outside the patient.An attempt was made to set the revolutions; however, the number of revolutions could not be read on the rotablator console.The rotalink plus was running for seconds.The physician felt a sharp pain on the thumb that was holding the sheath of the rotalink plus burr.Two small holes were observed on the sheath.Difficulty removing the rotalink plus from the rotawire occurred; therefore both devices were removed together as one.The tip of the rotawire was torn off into two short pieces and remain in the distal circumflex artery.No patient complications were reported and the patient's status was stable.It was further reported that the target lesion in the proximal circumflex was moderately tortuous and severely calcified.The detached rotawire pieces remained in the patient due to the flow of the vessel was good.The patient is scheduled to return at a later date to treat the lesion.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of the rotablator rotalink plus atherectomy device.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device revealed that the sheath was split with the burr partially within the sheath.Two holes in the sheath were identified at 123mm and 129.5mm distal from the strain relief.Functional testing was performed with the returned rotawire.The rotawire was able to be removed and reinserted into the device with resistance due to kinks in the wire.Upon inspection of the wire, it was found that the spring tip had been fractured.Product analysis confirmed the reported events, as the resistance during wire insertion and removal is attributable to the reported difficulties in removing the wire, and there was a fracture at the rotawire spring tip.

• 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: 11874123
• MDR Text Key: 252308605
• Report Number: 2134265-2021-06694
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• 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,Followup
• Report Date: 07/01/2021

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: 11/01/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0024857703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 05/25/2021; 06/24/2021
• Supplement Dates FDA Received: 06/08/2021; 07/01/2021
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: FINECROSS; GUIDE CATHETER: FINECROSS; GUIDE CATHETER: FINECROSS; GUIDE CATHETER: FINECROSS
• Patient Outcome(s): Other