MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY

Model Number	3320
Medical Device Problem Codes	Fracture (1260); Device Damaged by Another Device (2915); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a rotawire fracture occurred.A 330cm rotawire was being used with a 1.5mm rotalink burr.Ablation was successful.The physician then exchanged the 1.5mm burr with a 2.0mm rotalink.The 2.0mm rotalink burr advanced over the same 330cm rotawire without friction.Rotational testing was performed outside of the patient at 180,000 rpm which resulted in the 330cm rotawire becoming fractured.The devices were exchanged with another same device.No patient complications were reported and the patient was doing well and stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: the handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.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.The coil is stretched.Functional testing was performed using a test.009 rotawire.The test rotawire was inserted through the burr and advanced through the entire length of the device with no resistance.Product analysis did not confirm the reported event.
Event or Problem Description
It was reported that a rotawire fracture occurred.A 330cm rotawire was being used with a 1.5mm rotalink burr.Ablation was successful.The physician then exchanged the 1.5mm burr with a 2.0mm rotalink.The 2.0mm rotalink burr advanced over the same 330cm rotawire without friction.Rotational testing was performed outside of the patient at 180,000 rpm which resulted in the 330cm rotawire becoming fractured.The devices were exchanged with another same device.No patient complications were reported and the patient was doing well and stable post procedure.

• Brand Name: ROTALINK BURR
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8658299
• Report Number: 2134265-2019-06108
• Device Sequence Number: 2299260
• Product Code: MCX
• UDI-Device Identifier: 08714729126881
• UDI-Public: 08714729126881
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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: 06/10/2019
• Device Model Number: 3320
• Device Catalogue Number: 3320
• Device Lot Number: 0020863288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROTAWIRE AND WIRECLIP TORQUER; ROTAWIRE AND WIRECLIP TORQUER; ROTAWIRE AND WIRECLIP TORQUER