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

Model Number 3243

Device Problems Entrapment of Device (1212); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the burr would not advance over the guidewire.A 1.5mm rotapro was selected for an atherectomy procedure.During withdrawal, in dynaglide mode, the burr was no longer advancing over the wire.The rotapro and wire were removed together from the patient.The procedure was completed and there were no patient complications.

Event Description

It was reported that the burr would not advance over the guidewire.A 1.5mm rotapro was selected for an atherectomy procedure.During withdrawal, in dynaglide mode, the burr was no longer advancing over the wire.The rotapro and wire were removed together from the patient.The procedure was completed and there were no patient complications.It was further reported that the issue occurred when the device was rotating in dynaglide mode in order to advance the burr to the lesion.It occurred after the wire had passed through the device.

Manufacturer Narrative

E1: initial reporter state: (b)(6).Updated device analysis by mfr: the returned product consisted of a rotapro device.The advancer unit and burr catheter were received together.The rotawire used during the procedure was not returned for investigation.The advancer, coil, sheath, handshake connections, 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.As the rotawire that was used during the procedure was not returned; 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.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate.Product analysis confirmed the reported event due to the melted ultem.As the device was unable to run, the brake function was unable to be tested.Visual inspection of the brake showed no irregularities or damage.Inspection of the remainder of the device presented no other damage or irregularities.

Manufacturer Narrative

E1: initial reporter state: (b)(6).Device returned and evaluated by manufacturer.The returned product consisted of a rotapro device.The advancer unit and burr catheter were received together.The rotawire used during the procedure was not returned for investigation.The advancer, coil, sheath, handshake connections, 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.As the rotawire that was used during the procedure was not returned; 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.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the burr would not advance over the guidewire.A 1.5mm rotapro was selected for an atherectomy procedure.During withdrawal, in dynaglide mode, the burr was no longer advancing over the wire.The rotapro and wire were removed together from the patient.The procedure was completed and there were no patient complications.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9491552
• MDR Text Key: 173314511
• Report Number: 2134265-2019-15799
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2021
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0024388672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/24/2020; 02/19/2020
• Supplement Dates FDA Received: 02/10/2020; 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1