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

Model Number 3241

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Event Description

It was reported that device detachment occurred during preparation.The eccentric target lesion area was located in the mildly tortuous and severely calcified left anterior descending artery.A rotablator rotalink plus 1.25mm burr and 330cm rotawire were selected for use.During the draw process outside the patient, resistance was encountered when advancing the rotawire through the rotalink plus.The rotawire became stuck inside the rotalink plus.The physician forcefully withdrew the devices.The proximal end of the rotalink plus detached.The procedure was completed with another of the same device.There were no patient complications reported and the patient is stable.

Event Description

It was reported that device detachment occurred during preparation.The eccentric target lesion area was located in the mildly tortuous and severely calcified left anterior descending artery.A rotablator rotalink plus 1.25mm burr and 330cm rotawire were selected for use.During the draw process outside the patient, resistance was encountered when advanciing the rotawire through the rotalink plus.The rotawire became stuck inside the rotalink plus.The physician forcefully withdrew the devices.The proximal end of the rotalink plus detached.The procedure was completed with another of the same device.There were no patient complicatons reported and the patient is stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device did not reveal any damages or defects.The wire used in the procedure was received, so the wire used in the procedure was also used for functional testing.The returned rotawire was able to be removed from the rotablator device, but was not able to be reinserted due to kinks at 2cm and 19cm from the proximal end of the wire.The rotablator advancer was then connected to the rotablator console control system.When the foot pedal was pressed, the advancer was able to reach and maintain optimal rpm without resistance or issues.

Manufacturer Narrative

F6 device codes corrected from detachment of device or device component a0501 to break a0401.Device evaluated by manufacturer: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device did not reveal any damages or defects.The wire used in the procedure was received, so the wire used in the procedure was also used for functional testing.The returned rotawire was able to be removed from the rotablator device, but was not able to be reinserted due to kinks at 2cm and 19cm from the proximal end of the wire.The rotablator advancer was then connected to the rotablator console control system.When the foot pedal was pressed, the advancer was able to reach and maintain optimal rpm without resistance or issues.

Event Description

It was reported that device detachment occurred during preparation.The eccentric target lesion area was located in the mildly tortuous and severely calcified left anterior descending artery.A rotablator rotalink plus 1.25mm burr and 330cm rotawire were selected for use.During the draw process outside the patient, resistance was encountered when advancing the rotawire through the rotalink plus.The rotawire became stuck inside the rotalink plus.The physician forcefully withdrew the devices.The proximal end of the rotalink plus detached.The procedure was completed with another of the same device.There were no patient complications reported and the patient 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; model farm road; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12232419
• MDR Text Key: 263818763
• Report Number: 2134265-2021-09643
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2022

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: 12/05/2022
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0026575704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 09/16/2021; 02/10/2022
• Supplement Dates FDA Received: 10/06/2021; 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1