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

Model Number	29720
Medical Device Problem Codes	Contamination (1120); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was difficult to remove due to foreign material.The 100% stenosed target lesion was located in a mildly tortuous and mildly calcified popliteal lesion.A rotalink plus 2.00mm was selected for treatment.It was noted that the rotalink plus 2.00mm was difficult to remove.Material was wrapped around the shaft of the rotalink plus 2.00mm.The rotalink plus 2.00mm was removed without intervention.No patient complications were reported.
Event or Problem Description
It was reported that the catheter was difficult to remove due to foreign material.The 100% stenosed target lesion was located in a mildly tortuous and mildly calcified popliteal lesion.A rotalink plus 2.00mm was selected for treatment.It was noted that the rotalink plus 2.00mm was difficult to remove.Material was wrapped around the shaft of the rotalink plus 2.00mm.The rotalink plus 2.00mm was removed without intervention.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.Returned product consisted of the peripheral rotalink plus atherectomy device.A piece of material was included within a ziploc bag with notation identifying the material as the same as depicted in an attached photo.The advancer, drive shaft, and handshake connection were visually and microscopically examined.Inspection of the device found additional fm material on the coil resembling the material received within the ziploc bag.There were no further damages or irregularities identified to the device.In order to determine the nature of the foreign material, an ftir was used and found that the material most closely resembled ptfe [teflon] from within a guide catheter.Product analysis confirmed the reported event, as there was ptfe material identified on the coil during inspection.It is likely that the reported difficulty withdrawing the device was attributable to interference from the ptfe material.

• Brand Name: PERIPHERAL ROTALINK PLUS
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12705185
• Report Number: 2134265-2021-13519
• Device Sequence Number: 18342817
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K121774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2023
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0027671736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White