MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3851

Device Problems Break (1069); Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 02/24/2023

Event Type  Injury  

Event Description

It was reported that removal difficulties and shaft detachment occurred.The patient previously underwent percutaneous coronary intervention (pci) a couple days earlier to a very calcified lesion within the right coronary artery (rca).Vascular access was gained via left groin with 7f non-boston scientific guide catheter.The left anterior descending artery (lad) was calcified from a to b-segment.The lad was wired with a non-boston scientific guidewire.A 2.5mm balloon pre-dilated the lesion.Intravascular ultrasound (ivus) was performed which revealed a very calcified lad with up to local 360-degree calcification.The 3.25mmx10mm wolverine cutting balloon was advanced.The wolverine cutting balloon could not cross to the distal lesion.Dilatation was performed from the a segment and gradually advance into b-segment of the lad.Balloon was dilated to 10 atm.Upon retrieval, the wolverine got stuck in the a-segment.In attempts to remove the wolverine, the balloon was dilated several times and moved forward and backwards.The wolverine remained stuck.The wolverine was pulled hard during removal attempts and the the shaft elongate slightly.The physician elected to cut the proximal part of the wolverine and inserted a 6f guidezilla.The wolverine was pulled again but remained stuck.The shaft of the wolverine snapped.The 6f guidezilla was exchanged with a 7f guidezilla.A guidewire was advanced past the stuck wolverine with the help of a microcatheter.Dilation was performed using a 1.5mm balloon to aid is dislodging the stuck wolverine.The wolverine was still stuck.Ivus was performed to assess the situation.Dilation continued with a 2mm balloon distally to the wolverine balloon.The wolverine moved slightly distally.The wolverine was dislodged and was able to be retracted into the guidezilla by pulling the dilatated 2mm balloon.Pci continued with boston nc balloon and finished with a promus premier stent distally and syngery megatron left anterior descending artery to the left main.Ivus confirmed good results.I believe the wolverine got stuck in the calcium.I don't know what i could have done wrong or differently.Fortunately, i was able to retrieve it with the help of a guidezilla and dilated 2mm balloon.No patient harm resulted in relation to this event.The patient fully recovered.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16593187
• MDR Text Key: 311789793
• Report Number: 2124215-2023-13581
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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