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); Output Problem (3005)

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

Event Date 09/07/2023

Event Type  Injury  

Event Description

It was reported that the burr stuck in the lesion occurred requiring additional emergency surgery.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified ostioproximal left anterior descending artery (lad).A 1.50mm rotablator rotalink plus was selected for percutaneous transluminal coronary angioplasty (ptca).During the procedure, the physician attempted a rota assited ptca on a diffused lad lesion.While rotablating the ostio proximal lad, due to severely diffused calcium, the physician connveyed and experienced a significant resistance in advancing the burr.The burr got stuck and was entrapped in the severely calcified segment.The physician performed manual traction and had to cut the burr and sheath together to retrieve the stuck burr and pulled out using a guide-extension catheter but failed.Then, they once again attempted with another rotalink 1.5mm burr that was able to pass through the lesion and ablate the calcium.The procedure was completed with another of the same device.No further complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.Inspection of the device found that the sheath was torn and that the coil was kinked, stretched, and detached at 4cm distal from the burr housing strain relief.A photo of documentation was attached to the complaint record, but no photos of the device were provided.The device was not able to be functionally tested due to the damage to the coil and sheath.

Event Description

It was reported that the burr stuck in the lesion occurred requiring additional emergency surgery.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified ostioproximal left anterior descending artery (lad).A 1.50mm rotablator rotalink plus was selected for percutaneous transluminal coronary angioplasty (ptca).During the procedure, the physician attempted a rota assited ptca on a diffused lad lesion.While rotablating the ostio proximal lad, due to severely diffused calcium, the physician connveyed and experienced a significant resistance in advancing the burr.The burr got stuck and was entrapped in the severely calcified segment.The physician performed manual traction and had to cut the burr and sheath together to retrieve the stuck burr and pulled out using a guide-extension catheter but failed.Then, they once again attempted with another rotalink 1.5mm burr that was able to pass through the lesion and ablate the calcium.The procedure was completed with another of the same device.No further complications were reported.

• 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 CORK LIMITED; 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: 17970393
• MDR Text Key: 326120178
• Report Number: 2124215-2023-58100
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729228363
• UDI-Public: 08714729228363
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3241
• Device Catalogue Number: 3241
• Device Lot Number: 0030719105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Race: Asian