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

Model Number 29720

Device Problems Contamination (1120); Difficult to Remove (1528)

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

Event Date 10/15/2021

Event Type  malfunction  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 278601825
• Report Number: 2134265-2021-13519
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 08714729838920
• UDI-Public: 08714729838920
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White