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

Model Number 2077-01

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problems Anxiety (2328); Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 07/05/2023

Event Type  Death  

Event Description

It was reported, that the rotawire detached.And patient underwent open-heart surgery and died.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).During the procedure, unknown workhorse wire was used to cross the lesion.And a non-boston scientific microcatheter was placed over the workhorse up to the lesion, but it could not cross the lesion.Then, a rotawire drive was selected for percutaneous coronary intervention (pci) and atherectomy procedure.The rotawire advanced the lesion and down the vessel.However, it was noted, that it started to prolapse on itself, so the physician started to pull it back to straighten the wire.The rotawire detached at mid lad, when it was pinched on calcium and became stuck at the radiopaque section.Consequently, the physician had to pull the wire back aggressively, the rotawire looked like it uncoiled, and the detached portion of the distal tip of the rotawire remains inside the patient.The patient experienced anxiety.The physician, then decided to do an open-heart surgery, but the patient passed during surgery.

Event Description

It was reported that the rotawire detached, and patient underwent open-heart surgery and died.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).During the procedure, unknown workhorse wire was used to cross the lesion and a non-boston scientific microcatheter was placed over the workhorse up to the lesion, but it could not cross the lesion.Then, a rotawire drive was selected for percutaneous coronary intervention (pci) and atherectomy procedure.The rotawire advanced the lesion and down the vessel.However, it was noted that it started to prolapse on itself, so the physician started to pull it back to straighten the wire.The rotawire detached at mid lad when it was pinched on calcium and became stuck at the radiopaque section.Consequently, the physician had to pull the wire back aggressively, the rotawire looked like it uncoiled, and the detached portion of the distal tip of the rotawire remains inside the patient.The patient experienced anxiety.The physician then decided to do an open-heart surgery, but the patient passed during surgery.

Manufacturer Narrative

Device evaluated by manufacturer: the device returned for analysis.Visual and microscopic inspection found that the device was returned without the spring tip.The distal tip of the guidewire was bent/kinked.Inspection of the remainder of the device, revealed no damage or irregularities.

• Brand Name: ROTAWIRE DRIVE
• 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; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17400639
• MDR Text Key: 319827245
• Report Number: 2124215-2023-38223
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

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: 2077-01
• Device Catalogue Number: 2077-01
• Device Lot Number: 0031053099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• 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: TELEPORT MICROCATHETER - ORBUSNEICH MEDICAL; TELEPORT MICROCATHETER - ORBUSNEICH MEDICAL
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female