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

Model Number	29720
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the burr and rotawire detached and was left inside patient's body.The target lesion was located in the left anterior tibial vessel.A 1.75mm peripheral rotalink plus and a rotawire were selected for use.During the procedure, atherectomy got through the lesion.However, when the 1.75mm peripheral rotalink plus was taken out, it was noted that the burr head was not moving.After retracting the entire catheter, the burr head is still inside.Then, when the rotawire was taken out, the physician further noted that a piece of the wire and the burr head were left inside the patient.Consequently, the physician tried to snare the fragments out; however, it was unable to be snared so the physician completed the procedure to make sure the patient still had runoff in the foot and they were done.The procedure was completed with the same device.The physician talked with the patient and they may have to take him to surgery to take it out.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically exanimated.Visual examination revealed that the coil is separated 148.4cm from the handshake connection.The burr is missing.Microscopic examination revealed no additional damages.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate due to a melted ultem.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the burr and rotawire detached and was left inside patient's body.The target lesion was located in the left anterior tibial vessel.A 1.75mm peripheral rotalink plus and a rotawire were selected for use.During the procedure, atherectomy got through the lesion.However, when the 1.75mm peripheral rotalink plus was taken out, it was noted that the burr head was not moving.After retracting the entire catheter, the burr head is still inside.Then, when the rotawire was taken out, the physician further noted that a piece of the wire and the burr head were left inside the patient.Consequently, the physician tried to snare the fragments out; however, it was unable to be snared so the physician completed the procedure to make sure the patient still had runoff in the foot and they were done.The procedure was completed with the same device.The physician talked with the patient and they may have to take him to surgery to take it out.No further patient complications were reported.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9781374
• Report Number: 2134265-2020-02424
• Device Sequence Number: 504383
• Product Code: MCW
• UDI-Device Identifier: 08714729838913
• UDI-Public: 08714729838913
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/22/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0024152633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention