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

Model Number 3241

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2020

Event Type  malfunction  

Event Description

It was reported that the burr became stuck in the lesion and the drive shaft sheath detachment occurred.The 90% stenosed, 24mm x3.0mm target lesion was in a moderately tortuous and severely calcified proximal to mid left anterior descending artery.A 7f guide catheter was in use with a 1.5mm rotaburr.The burr was upsized to a 2.0mm rotalink plus and ablation was performed over 150,000 rpm within 20 seconds each ablation.The burr then became stuck in the lesion due to the lesion characteristics.Consequently, the shaft was cut and the 7f guide catheter was deep seated in attempts to remove the burr.During withdrawal, the drive shaft sheath could not be removed and eventually the drive shaft sheath detached as a result of continuous pulling.Eventually the device was removed together with the system without any fragments left unretrieved.No patient complications were reported, and the patient condition is stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The sheath, coil, burr and annulus were visually and microscopically examined.The sheath and coil is stretched and separated/torn 139.4cm from the burr, the handshake connection was not returned.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.The proximal end of the separated sheath is stretched and has numerous kinks.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the burr became stuck in the lesion and the drive shaft sheath detachment occurred.The 90% stenosed, 24mm x3.0mm target lesion was in a moderately tortuous and severely calcified proximal to mid left anterior descending artery.A 7f guide catheter was in use with a 1.5mm rotaburr.The burr was upsized to a 2.0mm rotalink plus and ablation was performed over 150,000rpm within 20seconds each ablation.The burr then became stuck in the lesion due to the lesion characteristics.Consequently, the shaft was cut and the 7f guide catheter was deep seated in attempts to remove the burr.During withdrawal, the drive shaft sheath could not be removed and eventually the drive shaft sheath detached as a result of continuous pulling.Eventually the device was removed together with the system without any fragments left unretrieved.No patient complications were reported, and the patient condition is stable.

• 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: 9673239
• MDR Text Key: 179241072
• Report Number: 2134265-2020-00926
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• 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: 03/02/2020

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: 07/30/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0024356027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• Supplement Dates FDA Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CATHETER GUIDE: 7F GUIDEZILLA II; CATHETER GUIDE: 7F GUIDEZILLA II; GUIDEWIRE: ROTAWIRE FLOPPY; GUIDEWIRE: ROTAWIRE FLOPPY; IMAGING CATHETER: OFDI FASTVIEW; IMAGING CATHETER: OFDI FASTVIEW