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

Model Number 3241

Device Problems Entrapment of Device (1212); Failure to Advance (2524); Material Deformation (2976); Mechanical Jam (2983)

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

Event Date 03/21/2024

Event Type  malfunction  

Event Description

It was reported that device entrapment occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the middle third of a slightly to moderately tortuous and moderately to severely calcified vessel.A 6f non-boston scientific guide catheter was placed.A 330cm rotawire and wireclip torquer and a 1.25mm rotablator rotalink plus were selected for use.The procedure began with positioning the rotawire in the distal lesion and advancing the rotalink plus without using the dynaglide.The burr did not come out the tip of the guide catheter.Dynaglide and pushing maneuvers were done several times but the rotawire began moving away from its distal position.The burr and rotawire had to be removed together and were removed without the aid of dynaglide.An attempt was made to reposition the system by removing the rotawire from the advancer, however, the wire did not come out.As attempts were made to remove the wire, the burr was bent but the wire did not move.The decision was made to reschedule the procedure.There were no patient complications.

Manufacturer Narrative

The device was not returned for analysis; therefore, product analysis was not possible.However, a media provided by the customer showing that the sheath was damaged/bent in accordance with the sheath damage within the reported events.The damage shown to the sheath is commonly associated with resistance encountered when attempting to remove the rotawire.

Event Description

It was reported that device entrapment occurred.Vascular access was obtained via the femoral artery.The target lesion was located in the middle third of a slightly to moderately tortuous and moderately to severely calcified vessel.A 6f non-boston scientific guide catheter was placed.A 330cm rotawire and wireclip torquer and a 1.25mm rotablator rotalink plus were selected for use.The procedure began with positioning the rotawire in the distal lesion and advancing the rotalink plus without using the dynaglide.The burr did not come out the tip of the guide catheter.Dynaglide and pushing maneuvers were done several times but the rotawire began moving away from its distal position.The burr and rotawire had to be removed together and were removed without the aid of dynaglide.An attempt was made to reposition the system by removing the rotawire from the advancer, however, the wire did not come out.As attempts were made to remove the wire, the burr was bent but the wire did not move.The decision was made to reschedule the procedure.There were no patient complications.

• Brand Name: ROTALINK PLUS
• 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19073926
• MDR Text Key: 339884370
• Report Number: 2124215-2024-19670
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729316411
• UDI-Public: 08714729316411
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

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: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0031949188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• 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
• Treatment: GUIDE CATHETER - 6F LAUNCHER; GUIDE CATHETER - 6F LAUNCHER
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Race: Asian