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

Model Number 3241

Device Problems Break (1069); Device Contamination with Body Fluid (2317); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2021

Event Type  malfunction  

Event Description

It was reported that there was air leak in the catheter.The target lesion was located in the coronary artery.A 1.50mm rotalink plus was selected for use.The device was prepped, rotablation was tested 180,000 revs and hydrated with the pressurized hep saline in adequate drip rate.During procedure, the device was advance over the rotawire and into the guide catheter through hemostasis valve but blood was retrogradely advancing through the sheath.Upon further inspection, the entire shaft of the catheter was filled with blood and there was also blood in the plastic mechanism.The burr was disconnected from the advancer to check for antegrade fluid movement.When the burr was then connected back onto the advancer, an air was visibly present in the sheath.The procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: details of analysis: returned product consisted of the rotablator rotalink plus atherectomy device.The burr catheter was received connected to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device revealed that the coil was kinked and stretched at the handshake connection.Additionally, blood was identified within the body of the advancer.In order to troubleshoot the reported gas leak, functional testing was performed.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.Then functional testing was performed by connecting the rotablator advancer to the rotablator control console system.When the knob switch was pushed, the advancer didnt get any speed and a stall error was displayed on the console.The advancer was dismantled and there were no damages or irregularities found.Product analysis confirmed the reported event, as the device was received with blood within the advancer.The reported gas leak could not be confirmed, as the device stalled and would not run.

Event Description

It was reported that there was air leak in the catheter and entire shaft filled with blood.The target lesion was located in the coronary artery.A 1.50mm rotalink plus was selected for use.The device was prepped, rotablation was tested 180,000 revs and hydrated with the pressurized hep saline in adequate drip rate.During procedure, the device was advance over the rotawire and into the guide catheter through hemostasis valve but blood was retrogradely advancing through the sheath.Upon further inspection, the entire shaft of the catheter was filled with blood and there was also blood in the plastic mechanism.The burr was disconnected from the advancer to check for antegrade fluid movement.When the burr was then connected back onto the advancer, an air was visibly present in the sheath.The procedure was completed with another of same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: the returned product consisted of the rotablator rotalink plus atherectomy device.The burr catheter was received connected to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device revealed that the coil was kinked and stretched at the handshake connection.Additionally, blood was identified within the body of the advancer.In order to troubleshoot the reported gas leak, functional testing was performed.Functional testing was performed by attempting to rotate the drive shaft, and the drive shaft was able to be rotated.Then functional testing was performed by connecting the rotablator advancer to the rotablator control console system.When the knob switch was pushed, the advancer didnt get any speed and a stall error was displayed on the console.The advancer was dismantled and there were no damages or irregularities found.Product analysis confirmed the reported event, as the device was received with blood within the advancer.

Event Description

It was reported that there was air leak in the catheter and entire shaft filled with blood.The target lesion was located in the coronary artery.A 1.50mm rotalink plus was selected for use.The device was prepped, rotablation was tested 180,000 revs and hydrated with the pressurized hep saline in adequate drip rate.During procedure, the device was advance over the rotawire and into the guide catheter through hemostasis valve but blood was retrogradely advancing through the sheath.Upon further inspection, the entire shaft of the catheter was filled with blood and there was also blood in the plastic mechanism.The burr was disconnected from the advancer to check for antegrade fluid movement.When the burr was then connected back onto the advancer, an air was visibly present in the sheath.The procedure was completed with another of same device.No patient complications were reported.

• 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: 11693572
• MDR Text Key: 246266158
• Report Number: 2134265-2021-05046
• 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: 05/25/2021

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: 10/24/2022
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0026406162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 04/21/2021; 05/11/2021
• Supplement Dates FDA Received: 05/12/2021; 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1