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

Model Number	3241
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event- 18 years or older.
Event or Problem Description
It was reported that the burr and wire became stuck.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 2.0 mm rotalink plus and a 330 cm rotawire were selected for use.During procedure, after rotation test outside the patient's body, the burr was advanced inside the guiding catheter.However, the burr got stuck in the guiding catheter before the secondary curve.Subsequently, the wire and burr got stuck and could not be advanced or returned.The burr was then removed together with the wire.The procedure was completed with another of the same device.No complications were reported.
Additional Manufacturer Narrative
A2: age at time of event- 18 years or older.Device evaluated by mfr.: the device was returned for analysis.The advancer, handshake connection, sheath, coil, burr and annulus were microscopically 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 was stretched.Functional testing was performed using a test.009 rotawire.The test rotawire was inserted through the burr tip and advanced through the entire length of the device with no resistance.Since the guide catheter used in the procedure was not returned for product analysis functional testing was completed with a test 7f (id of 0.081") guide catheter.The rotalink burr catheter was able to be inserted and advanced through the guide catheter with no resistance.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate due to the melted ultem.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the burr and wire became stuck.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 2.0mm rotalink plus and a 330cm rotawire were selected for use.During procedure, after rotation test outside the patient's body, the burr was advanced inside the guiding catheter.However, the burr got stuck in the guiding catheter before the secondary curve.Subsequently, the wire and burr got stuck and could not be advanced or returned.The burr was then removed together with the wire.The procedure was completed with another of the same device.No complications were reported.

• 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: 8713714
• Report Number: 2134265-2019-07101
• Device Sequence Number: 19498845
• Product Code: MCX
• UDI-Device Identifier: 08714729316442
• UDI-Public: 08714729316442
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/02/2019

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: 09/14/2020
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0022791955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 05/27/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1