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

Model Number 3241

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2019

Event Type  malfunction  

Event Description

It was reported that blood came out from the burr tip and shaft.The 90% stenosed target lesion was located in the severely calcified artery.Post ablation, the 1.50mm burr was taken removed from the patient's body and imaging was performed.Subsequently, additional ablation using the 1.50mm was considered after imaging.However, there were no saline flow from the burr and driving shaft when the burr was tried to advance inside the body along with the wire.The pressure bag was checked, 300psi, the drip line was opened, and there was no abnormality observed on the line connection.The syringe was reconnected in the cocktail line.Blood was then noted coming out from the burr tip and shaft when flushing was performed forcibly.The procedure was completed with a new burr.No complications were reported and patient condition was good.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The returned complaint device consisted of a rotablator rotalink plus device.The advancer, handshake connection, sheath, coil, burr and annulus were microscopically examined.Microscopic examination of the device revealed that the annulus was damaged/fish-mouthed which is consistent with damage seen with the use of a rotawire.The coil is stretched.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate.Product analysis confirmed the reported event due to the melted ultem.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.

Event Description

It was reported that blood came out from the burr tip and shaft.The 90% stenosed target lesion was located in the severely calcified artery.Post ablation, the 1.50mm burr was taken removed from the patient's body and imaging was performed.Subsequently, additional ablation using the 1.50mm was considered after imaging.However, there were no saline flow from the burr and driving shaft when the burr was tried to advance inside the body along with the wire.The pressure bag was checked, 300psi, the drip line was opened, and there was no abnormality observed on the line connection.The syringe was reconnected in the cocktail line.Blood was then noted coming out from the burr tip and shaft when flushing was performed forcibly.The procedure was completed with a new burr.No complications were reported and patient condition was good.

Event Description

It was reported that blood came out from the burr tip and shaft.The 90% stenosed target lesion was located in the severely calcified artery.Post ablation, the 1.50mm burr was taken removed from the patient's body and imaging was performed.Subsequently, additional ablation using the 1.50mm was considered after imaging.However, there were no saline flow from the burr and driving shaft when the burr was tried to advance inside the body along with the wire.The pressure bag was checked, 300psi, the drip line was opened, and there was no abnormality observed on the line connection.The syringe was reconnected in the cocktail line.Blood was then noted coming out from the burr tip and shaft when flushing was performed forcibly.The procedure was completed with a new burr.No complications were reported and patient condition was good.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The returned complaint device consisted of a rotablator rotalink plus device.The burr catheter was received attached to the advancer unit.There is blood in the housing.The advancer, handshake connection, sheath, coil, burr and annulus were microscopically examined.Microscopic examination of the device revealed that the annulus was damaged/fish-mouthed which is consistent with damage seen with the use of a rotawire.The coil is stretched.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate.Product analysis confirmed the reported event due to the melted ultem.Functional testing was performed by hooking the rotablator plus device to a pressurized bag of water.The water was flushed quickly through the entire length of the sheath exiting the distal end of the sheath with no leaks or issues.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.

• 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: 9252018
• MDR Text Key: 165422492
• Report Number: 2134265-2019-13087
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• 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: 12/06/2019

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 Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0023999520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Manufacturer Received: 10/07/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 11/01/2019; 11/25/2019
• Supplement Dates FDA Received: 11/20/2019; 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1