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

Model Number	3241
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that flush cocktail leaked.A 2.00mm rotalink plus was selected for use.During preparation, it was noted that the flush cocktail leaked halfway up the catheter and there was a hole.The flush cocktail would not go through the catheter.It was never used inside patient.The procedure was completed with another of the same device.No complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned complaint device consisted of a rotablator plus device.The burr catheter was attached to the advancer when received and the knob was in the locked proximal location.The advancer, handshake connection, sheath, coil, burr and annulus were microscopically and visually examined.Visual examination revealed multiple wear marks along the sheath.The wear marks go through the sheath in some areas causing small holes.Microscopic examination revealed that the coil is stretched.Functional testing was performed by rotating the drive shaft and it was unable to rotate.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damages on the device that could have contributed to the reported event.
Event or Problem Description
It was reported that flush cocktail leaked.A 2.00mm rotalink plus was selected for use.During preparation, it was noted that the flush cocktail leaked halfway up the catheter and there was a hole.The flush cocktail would not go through the catheter.It was never used inside patient.The procedure was completed with another of the same device.No complications were reported and patient was stable post procedure.

• Brand Name: ROTALINK PLUS
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9793160
• Report Number: 2134265-2020-02550
• Device Sequence Number: 11345571
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P900056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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: 03/29/2021
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0023708010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/16/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1