MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK¿ PLUS; CATHETER, CORONARY, ATHERECTOMY

Model Number H749236310040

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

Age at the time of event: 18 years or older.(b)(4).

Event Description

It was reported that the tip became separated from the shaft.The 90% stenosed target lesion was located in a severely tortuous and severely calcified proximal right coronary artery (rca).A 1.75 mm rotalink¿ plus was selected for use.During procedure, an ivus catheter failed to cross the lesion, thus, rotablation was performed.Upon second ablation, the rotation speed decreased by 20,000 rpm.Subsequently, while the burr was rotating at 130,000 rpm, it was noted that the tip and the shaft of the burr became separated.The separated burr was trapped in the lesion, thus, a pci guidewire passed through beside the separated burr component.The separated burr component was then retrieved after a 2 mm non bsc balloon catheter was repeatedly inflated and deflated and the burr was pulled together with the non bsc guide catheter.A stent was then place in the target lesion and the procedure was completed.The patient remained stable and no further patient complications reported.

Manufacturer Narrative

Updated device evaluated by mfr., eval summary attached, method codes, result codes and conclusion codes.Device evaluated by mfr: the device was returned for analysis.Returned product consisted of the rotablator rotalink plus device.The advancer unit and burr unit were received together.A rotawire was also returned with the burr on it, the burr was able to slide off of the wire with no issues.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically and visually examined.The burr is separated from the coil.The annulus is damaged/not rounded.This type of damage is consistent with damage caused by the interaction of a guidewire.The coil is stretched and broken.Coil fragments can be seen inside of the proximal end of the burr.Inspection of the remainder of the device presented no other damage or irregularities.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that the tip became separated from the shaft.The 90% stenosed target lesion was located in a severely tortuous and severely calcified proximal right coronary artery (rca).A 1.75mm rotalink¿ plus was selected for use.During procedure, an ivus catheter failed to cross the lesion, thus, rotablation was performed.Upon second ablation, the rotation speed decreased by 20,000rpm.Subsequently, while the burr was rotating at 130,000rpm, it was noted that the tip and the shaft of the burr became separated.The separated burr was trapped in the lesion, thus, a pci guidewire passed through beside the separated burr component.The separated burr component was then retrieved after a 2mm non bsc balloon catheter was repeatedly inflated and deflated and the burr was pulled together with the non bsc guide catheter.A stent was then place in the target lesion and the procedure was completed.The patient remained stable and no further patient complications reported.

Event Description

It was reported that the tip became separated from the shaft.The 90% stenosed target lesion was located in a severely tortuous and severely calcified proximal right coronary artery (rca).A 1.75mm rotalink¿ plus was selected for use.During procedure, an ivus catheter failed to cross the lesion, thus, rotablation was performed.Upon second ablation, the rotation speed decreased by 20,000rpm.Subsequently, while the burr was rotating at 130,000rpm, it was noted that the tip and the shaft of the burr became separated.The separated burr was trapped in the lesion, thus, a pci guidewire passed through beside the separated burr component.The separated burr component was then retrieved after a 2mm non bsc balloon catheter was repeatedly inflated and deflated and the burr was pulled together with the non bsc guide catheter.A stent was then place in the target lesion and the procedure was completed.The patient remained stable and no further patient complications reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Returned product consisted of the rotablator rotalink plus device.The advancer unit and burr unit were received together.A rotawire was also returned with the burr on it, the burr was able to slide off of the wire with no issues.The advancer, coil, sheath, handshake connections, burr, and annulus were microscopically and visually examined.The burr is separated from the coil.The annulus is damaged/not rounded.This type of damage is consistent with damage caused by the interaction of a guidewire.The coil is stretched and broken.Coil fragments can be seen inside of the proximal end of the burr.Inspection of the remainder of the device presented no other damage or irregularities.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

• Brand Name: ROTALINK¿ PLUS
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 7650369
• MDR Text Key: 112726705
• Report Number: 2134265-2018-05954
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228370
• UDI-Public: 08714729228370
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 06/13/2018

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: 10/14/2019
• Device Model Number: H749236310040
• Device Catalogue Number: 23631-004
• Device Lot Number: 0021377410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: 7F AL1 LAUNCHER; GUIDEWIRE: ROTAWIRE FLOPPY; GUIDE CATHETER: 7F AL1 LAUNCHER; GUIDEWIRE: ROTAWIRE FLOPPY
• Patient Outcome(s): Required Intervention