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

Model Number 3241

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/05/2021

Event Type  malfunction  

Event Description

A foreign substance was found on the burr.The 98% stenosed target lesion area was located in a moderately tortuous and severely calcified proximal left anterior descending artery.A 1.50mm rotalink plus was selected for use in a percutaneous coronary intervention.During the procedure, the burr catheter was opened.However, it was noted that there was a foreign substance on the device.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

D4: lot number: updated to 0023999526.D4 expiration date: updated to 05/24/2021.D4 udi: updated to (b)(4).H4: manufacture date: updated to 06/24/2019.Device evaluated by manufacturer: the returned device consisted of the rotablator rotalink plus atherectomy device.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device revealed that 0.25cm of sheath material had been wrapped around the burr with the sheath having been torn.The torn sheath material indicates that the tuohy was tightened at the distal end, and the burr was pulled down into the sheath, causing it to twist until separated.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

A foreign substance was found on the burr.The 98% stenosed target lesion area was located in a moderately tortuous and severely calcified proximal left anterior descending artery.A 1.50mm rotalink plus was selected for use in a percutaneous coronary intervention.During the procedure, the burr catheter was opened.However, it was noted that there was a foreign substance on the device.The device was removed and the procedure was completed with another of the same device.There were no patient complications 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: 11566169
• MDR Text Key: 242727569
• Report Number: 2134265-2021-03394
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

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: 05/24/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0023999526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 04/21/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR