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

Model Number 3243

Device Problems Difficult to Remove (1528); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that removal difficulties occurred.A 1.25mm rotapro was selected for a percutaneous coronary intervention (pci) procedure of the circumflex artery (cfx).The rotapro was prepared and advanced to the target lesion.After the first ablation was completed successfully with 3-5 passes for 30 seconds, the device was put into dynaglide mode but it was difficult to remove from the patient and blood was observed in the sheath.The physician then removed the device by pulling the device.The procedure was completed with balloon angioplasty instead of rotapro.There were no patient complications reported and the patient's status was stable post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of a rotapro device.Visual inspection of the analysis of the returned product revealed that the rotawire was stuck in burr and able to be removed from the advancer unit; however the wire was unable to be removed from the burr catheter after being soaked in a water bath for 4 days.Microscopic examination of the device revealed that the coil is stretched and there is blood in the entire length of the sheath.Functional testing was performed by attempting to rotate the drive shaft, however, it was unable to rotate due to the melted ultem.A melted ultem is due to the interruption of saline, by insufficient flow of saline used during the preparation or during the procedure of the device.Inspection of the remainder of the device presented no other damage or irregularities.A2: age at time of event: 18 years or older.

Event Description

It was reported that removal difficulties occurred.A 1.25mm rotapro was selected for a percutaneous coronary intervention (pci) procedure of the circumflex artery (cfx).The rotapro was prepared and advanced to the target lesion.After the first ablation was completed successfully with 3-5 passes for 30 seconds, the device was put into dynaglide mode but it was difficult to remove from the patient and blood was observed in the sheath.The physician then removed the device by pulling the device.The procedure was completed with balloon angioplasty instead of rotapro.There were no patient complications reported and the patient's status was stable post procedure.

• 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: 9347998
• MDR Text Key: 170338642
• Report Number: 2134265-2019-14089
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 08714729893356
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

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
• Device Operator: Health Professional
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0023925840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 12/23/2019
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1