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); Deflation Problem (1149); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problems Ischemia (1942); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 04/17/2022

Event Type  Death  

Event Description

It was reported that the patient died.The target lesion was located in the severely calcified proximal left anterior descending artery (lad).A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the lesion was crossed and poba was performed with another manufacturers device, however, the indentation could not be obtained; therefore, this device was used and was delivered by advancing forward to the distal lad instead of the proximal due to calcification.The device was stuck after 5 dilatations and it has been noted, that there was resistance when it was attempted to remove the device during procedure.Subsequently, a guide only advanced when pulled but did not move and could not be pulled nor pushed, so a wire was inserted and recovered, however, it did not cross to the distal and the guiding catheter was difficult to insert (the proximal shaft has separated at this time).Therefore, a cabg was proposed; however a thrombus then flew into the circumflex obliteration and the patient died.The right coronary artery was originally quite thin and small; therefore, the wolverine that got stuck in the lad might have caused a total ischemic condition.When the wolverine was removed after the patient's death, it was pulled out without resistance.The procedure was discontinued due to the device defect.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device was returned without its manifold/hub present.A complete break in the hypotube was noted at approximately 103 cm proximal to the guidewire port.A tactile examination of the hypotube identified multiple hypotube kinks.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.A microscopic examination of the balloon identified no tears or holes in the balloon material.Three blades were present on the balloon surface, however, the following blade damage was noted on one blade.The distal blade segment was found to be lifted from its pad at the break point.No damage was noted with the pad of the blade.A visual and tactile examination found no damage along the shaft polymer extrusion.An examination of the tip section identified no issues.A visual and microscopic examination found no issue with the marker bands.Due to the condition of the returned device, with the break in the shaft, it was not possible to test for deflation.

Event Description

It was reported that the patient died.The target lesion was located in the severely calcified proximal left anterior descending artery (lad).A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the lesion was crossed and poba was performed with another manufacturers device, however, the indentation could not be obtained; therefore, this device was used and was delivered by advancing forward to the distal lad instead of the proximal due to calcification.The device was stuck after 5 dilatations and it has been noted, that there was resistance when it was attempted to remove the device during procedure.Subsequently, a guide only advanced when pulled but did not move and could not be pulled nor pushed, so a wire was inserted and recovered, however, it did not cross to the distal and the guiding catheter was difficult to insert (the proximal shaft has separated at this time).Therefore, a cabg was proposed; however a thrombus then flew into the circumflex obliteration and the patient died.The right coronary artery was originally quite thin and small; therefore, the wolverine that got stuck in the lad might have caused a total ischemic condition.When the wolverine was removed after the patient's death, it was pulled out without resistance.The procedure was discontinued due to the device defect.It was further reported that the physician noted the cause of death was a combination of multiple factors.The lad treatment had a significant effect on the patient; the procedure time was longer, a clot formed, and the clot in the catheter also covered the circumflex artery (cx), causing complete occlusion of the left main artery.The physician attempted to aspirate the clot up to about left main trunk (lmt), but was unable to do so up to cx.In addition, balloon dilation of the cx was performed.Because the patient was originally in the late stages of ovarian cancer and her prognosis was not long, placing percutaneous cardiopulmonary support (pcps) or performing surgery was not an option.Per physician's opinion on causal relationship with the product, is not directly, although there may have been some indirect involvement.The wolverine stuck and the procedure was prolonged, which may have caused clot formation as well as the activated clotting time (act) was not measured well during the procedure.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14255056
• MDR Text Key: 290441311
• Report Number: 2134265-2022-04973
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

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 Expiration Date: 11/19/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0028417954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2021
• 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): Other; Death
• Patient Age: 83 YR
• Patient Sex: Female