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

Model Number 3243

Device Problems Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problems Ischemia (1942); Myocardial Infarction (1969)

Event Date 05/04/2023

Event Type  Injury  

Event Description

It was reported the device was difficult to advance and ischemia, and myocardial infarction occurred.During a percutaneous coronary intervention (pci), the rotapro was difficult to advance and the knob did not have smooth movement.The device was replaced to resolve the issue.Ischemia and myocardial infarction was noted in the patient, during the device issue.No further complications reported and the patient was stable post procedure.

Manufacturer Narrative

Correction: (h6) patient code addition.Device evaluated by manufacturer: the returned product consisted of the rotapro atherectomy system.The burr catheter was connected to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.The advancer knob switch was in the backwards position when received and experienced resistance when attempting to move into the forward position.The housings were disconnected, and it was revealed the coil was kinked and stretched at the burr handshake connection.The knob switch was able to move back and forth with no resistance while the housings were disconnected.Product analysis confirmed the reported events, as the kinked and stretched coil caused resistance when attempting to move the advancer knob forward.

Event Description

It was reported the device was difficult to advance and ischemia, and myocardial infarction occurred.During a percutaneous coronary intervention (pci), the rotapro was difficult to advance and the knob did not have smooth movement.The device was replaced to resolve the issue.Ischemia and myocardial infarction was noted in the patient, during the device issue.No further complications reported and the patient was stable post procedure.

• 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 CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16991976
• MDR Text Key: 315838842
• Report Number: 2124215-2023-25902
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729893363
• UDI-Public: 08714729893363
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3243
• Device Catalogue Number: 3243
• Device Lot Number: 0031085633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2023
• 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