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

Model Number 39467-175

Device Problems Break (1069); Entrapment of Device (1212); Device Contamination with Body Fluid (2317); Failure to Advance (2524); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

It was reported that stuck on wire occurred.The target lesion was located in the mildly calcified and mildly tortuous circumflex artery.The 1.75 rotapro and rotawire were selected for use.When the burr was started up with the rotawire, angiographic image revealed the guide did not advance distal to the lesion and the burr did not advance.It was then noted that the transparent part of the rotapro catheter was filling with blood all over the patient.At the rotapro exit from the guide, it did not come out as it normally should so the decision was made to remove the burr and reload the system.An attempt was made to change the rotawire guide for an equal one.At the moment of wanting to remove the guide, it got stuck inside the rotapro catheter the physician decided to use another technique to complete the procedure.There were no patient complications and the patient fully recovered.

Event Description

It was reported that stuck on wire occurred.The target lesion was located in the mildly calcified and mildly tortuous circumflex artery.The 1.75 rotapro and rotawire were selected for use.When the burr was started up with the rotawire, angiographic image revealed the guide did not advance distal to the lesion and the burr did not advance.It was then noted that the transparent part of the rotapro catheter was filling with blood all over the patient.At the rotapro exit from the guide, it did not come out as it normally should so the decision was made to remove the burr and reload the system.An attempt was made to change the rotawire guide for an equal one.At the moment of wanting to remove the guide, it got stuck inside the rotapro catheter the physician decided to use another technique to complete the procedure.There were no patient complications and the patient fully recovered.It was reported that the patient was awake, and stable without any complications.

Manufacturer Narrative

Returned product consisted of the rotapro atherectomy system.The burr catheter was received attached to the advancer unit.The rotawire used in the procedure was returned within the rotapro device.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection found that the handshake connection was bent and broken.The reported blood in the device sheath was not identified during inspection.Functional testing was performed by attempting to remove the returned rotawire, and the returned rotawire was able to be removed with resistance due to the bent and broken handshake connection, but was not able to be reinserted into the device.Functional testing was then performed by connecting the rotapro advancer to the rotapro console control system.When the knob switch [ablation button] was pressed, the device stalled and would not run due to the bent and broken handshake connection.

Event Description

It was reported that stuck on wire occurred.The target lesion was located in the mildly calcified and mildly tortuous circumflex artery.The 1.75 rotapro and rotawire were selected for use.When the burr was started up with the rotawire, angiographic image revealed the guide did not advance distal to the lesion and the burr did not advance.It was then noted that the transparent part of the rotapro catheter was filling with blood all over the patient.At the rotapro exit from the guide, it did not come out as it normally should so the decision was made to remove the burr and reload the system.An attempt was made to change the rotawire guide for an equal one.At the moment of wanting to remove the guide, it got stuck inside the rotapro catheter the physician decided to use another technique to complete the procedure.There were no patient complications and the patient fully recovered.It was reported that the patient was awake, and stable without any complications.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road cork; cork IRELA ND; EI IRELAND
• Manufacturer Contact: jay johnson johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12911729
• MDR Text Key: 281591849
• Report Number: 2134265-2021-15140
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2022

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: 07/09/2023
• Device Model Number: 39467-175
• Device Catalogue Number: 39467-175
• Device Lot Number: 0027636777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 12/03/2021; 01/10/2022
• Supplement Dates FDA Received: 12/07/2021; 01/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female