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

Model Number 3280

Device Problems Break (1069); Unstable (1667); Material Integrity Problem (2978); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2019

Event Type  malfunction  

Event Description

It was reported that the speed was unstable.A rotalink advancer was selected for use.During preparation testing outside the patient's body and during the first pass within the patient's body the rotational speed as normal.However, there was a sudden speed increase that went up to 25w.Furthermore, it was noted that the burr could not move with the advancer.The device was removed and visual inspection did not identify any damage.The procedure was completed with this device.No patient complications were reported and the patient's status was stable.

Event Description

It was reported that the speed was unstable.A rotalink advancer was selected for use.During preparation testing outside the patient's body and during the first pass within the patient's body the rotational speed as normal.However, there was a sudden speed increase that went up to 25w.Furthermore, it was noted that the burr could not move with the advancer.The device was removed and visual inspection did not identify any damage.The procedure was completed with this device.No patient complications were reported and the patient's status was stable.It was further reported that the tip of the advancer was broken.

Manufacturer Narrative

Device evaluated by mfr: the rotalink advancer was returned for evaluation with the advancer knob observed to be tight in the forward position.The advancer and handshake connection were visually examined and noted that the handshake connection was bent.Functional testing observed that the drive shaft was unable to rotate.The ultem was melted.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the speed was unstable.A rotalink advancer was selected for use.During preparation testing outside the patient's body and during the first pass within the patient's body the rotational speed as normal.However, there was a sudden speed increase that went up to 25w.Furthermore, it was noted that the burr could not move with the advancer.The device was removed and visual inspection did not identify any damage.The procedure was completed with this device.No patient complications were reported and the patient's status was stable.It was further reported that the tip of the advancer was broken.

• Brand Name: ROTALINK ADVANCER
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8640918
• MDR Text Key: 146082139
• Report Number: 2134265-2019-05758
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729317739
• UDI-Public: 08714729317739
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Model Number: 3280
• Device Catalogue Number: 3280
• Device Lot Number: 0022119656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Manufacturer Received: 05/05/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 05/24/2019; 06/15/2019
• Supplement Dates FDA Received: 06/14/2019; 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 46