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

Model Number 39467-175

Device Problem Contamination (1120)

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

Event Date 11/24/2023

Event Type  malfunction  

Event Description

It was reported that the device was contaminated.Upon preparation, the 1.75mm rotapro was noted to be contaminated.The procedure was finished after replacing the burr.No complications were reported and patient was stable post procedure.

Event Description

It was reported that the device was contaminated.Upon preparation, the 1.75mm rotapro was noted to be contaminated.The procedure was finished after replacing the burr.No complications were reported and patient was stable post procedure.It was further reported that there was no problem with the product, but it occurred accidentally during the opening process outside patient's body.

Event Description

It was reported that the device was contaminated.Upon preparation, the 1.75mm rotapro was noted to be contaminated.The procedure was finished after replacing the burr.No complications were reported and patient was stable post procedure.It was further reported that there was no problem with the product, but it occurred accidentally during the opening process outside patient's body.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The burr catheter was received attached to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device found no damages or defects.

• Brand Name: ROTAPRO
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18359781
• MDR Text Key: 331192963
• Report Number: 2124215-2023-68789
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893356
• UDI-Public: 8714729893356
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2024

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: 39467-175
• Device Catalogue Number: 39467-175
• Device Lot Number: 0031327875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 12/14/2023; 02/06/2024
• Supplement Dates FDA Received: 01/05/2024; 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male