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

Model Number	29720
Medical Device Problem Codes	Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire broke off.The target lesion area was located in a mildly tortuous and severely calcified artery.A 1.50mm peripheral rotalink plus was selected for use along with a peripheral rotawire.During the procedure, the lesion was so severe that the device failed to advance.Subsequently, after two rotational runs of rotablator, it was noted that the wire snapped off at the end of the catheter and part of it remained inside the patient's body.The procedure was not completed.The patient was sent for a procedure to retrieve device fragments and it was successful.The patient was stable after the procedure.
Event or Problem Description
It was reported that the wire broke off.The target lesion area was located in a mildly tortuous and severely calcified artery.A 1.50mm peripheral rotalink plus was selected for use along with a peripheral rotawire.During the procedure, the lesion was so severe that the device failed to advance.Subsequently, after two rotational runs of rotablator, it was noted that the wire snapped off at the end of the catheter and part of it remained inside the patient's body.The procedure was not completed.The patient was sent for a procedure to retrieve device fragments and it was successful.The patient was stable after the procedure.It was further reported that the rotawire broke off during preparation and it was not inserted into the patient.The patient was sent to the hospital in a non-emergent/out-patient setting.
Additional Manufacturer Narrative
B1.Adverse event/product prob: updated from adverse event and product problem to product problem.B2.Outcomes attrib to adv event: updated from required intervention to prevent permanent impairment to not applicable.F10.Patient codes: updated from device fragments in patient 3165 to no consequences or impact to patient - 2199.H1: type of reportable event: updated from serious injury to malfunction.

• 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: 9632263
• Report Number: 2134265-2020-00471
• Device Sequence Number: 14120272
• Product Code: MCW
• UDI-Device Identifier: 08714729838906
• UDI-Public: 08714729838906
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 02/18/2020

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: 09/11/2021
• Device Model Number: 29720
• Device Catalogue Number: 29720
• Device Lot Number: 0024421604
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/18/2020
• 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: 71 YR