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

Model Number	29720
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that burr became stuck on guidewire and in the lesion.The target lesion was located in left superficial femoral artery.A 2.50mm peripheral rotalink plus was selected for use along with a rotawire.During procedure, the physician noted the burr became stuck in the forward-throw position.The rotawire and the burr catheter could not be pulled back as a system.It was thought that the catheter was stretched.The burr did not 'pop' through the lesion and the physician believed that the lesion was preventing him from removing the system or wire.There was no kink in the sheath or any other issue noted.A balloon was delivered alongside with the catheter and plasty the lesion.The system was removed as a unit without harm to the patient.A new 2.25mm burr was introduced to treat the lesion and completed the procedure without further complications.The patient was fine post procedure.
Event or Problem Description
It was reported that burr became stuck on guidewire and in the lesion.The target lesion was located in left superficial femoral artery.A 2.50mm peripheral rotalink plus was selected for use along with a rotawire.During procedure, the physician noted the burr became stuck in the forward-throw position.The rotawire and the burr catheter could not be pulled back as a system.It was thought that the catheter was stretched.The burr did not 'pop' through the lesion and the physician believed that the lesion was preventing him from removing the system or wire.There was no kink in the sheath or any other issue noted.A balloon was delivered alongside with the catheter and plasty the lesion.The system was removed as a unit without harm to the patient.A new 2.25mm burr was introduced to treat the lesion and completed the procedure without further complications.The patient was fine post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.There are numerous sheath kinks.The sheath is torn at the strain relief.The coil has become stretched due to manipulation during the procedure.Microscopic examination of the device revealed that the annulus was damaged and not rounded which is consistent with damage seen with the use of a rotawire.A device to device interaction test was performed by inserting a test guidewire into the device and it was able to pass through the entire device with no issues.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.

• 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: 10233438
• Report Number: 2134265-2020-08925
• Device Sequence Number: 3373790
• Product Code: MCW
• UDI-Device Identifier: 08714729838968
• UDI-Public: 08714729838968
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/28/2020

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: 02/09/2022
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0025186550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 08/28/2020
• 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: Required Intervention
• Patient Age: 66 YR