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 Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the blade was misaligned.The 90% stenosed target lesion was located in the severely calcified artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.At the end of the procedure, the device was removed without any resistance.However, it was noted that the blade was misaligned.The procedure was completed with a different device.There was no patient injury.

Event Description

It was reported that the blade was misaligned.The 90% stenosed target lesion was located in the severely calcified artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.At the end of the procedure, the device was removed without any resistance.However, it was noted that the blade was misaligned.The procedure was completed with a different device.There was no patient injury.It was further reported that after removal of the device, half of the one blade was missing.It was thought that this missing part was left inside the body.The other damaged piece was lost outside the body.A 3.0 wolverine coronary cutting balloon and 3.0/9 non boston scientific balloon of the same lot were used, but both got ruptured.Subsequently, after ablation with a rotalink 2.0mm, a 2.75/13 non boston scientific balloon was successfully dilated.The physician speculated that the cause was that the lesion was highly calcified and had to be dilated at high pressure at 20atm.The procedure was completed with implantation of 3.0/18 non boston scientific stent.The patient has already been discharged from the hospital and no complications were reported.

Manufacturer Narrative

E1: initial reporter address 1 - 1-1 (b)(6).H6: patient's code: foreign body in patient device code: detachment of device or device component.

Event Description

It was reported that the blade was misaligned.The 90% stenosed target lesion was located in the severely calcified artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.At the end of the procedure, the device was removed without any resistance.However, it was noted that the blade was misaligned.The procedure was completed with a different device.There was no patient injury.It was further reported that after removal of the device, half of the one blade was missing.It was thought that this missing part was left inside the body.The other damaged piece was lost outside the body.A 3.0 wolverine coronary cutting balloon and 3.0/9 non boston scientific balloon of the same lot were used, but both got ruptured.Subsequently, after ablation with a rotalink 2.0mm, a 2.75/13 non boston scientific balloon was successfully dilated.The physician speculated that the cause was that the lesion was highly calcified and had to be dilated at high pressure at 20atm.The procedure was completed with implantation of 3.0/18 non boston scientific stent.The patient has already been discharged from the hospital and no complications were reported.

Manufacturer Narrative

E1: initial reporter address 1 - (b)(6).Correction: h1 type of reportable event corrected from malfunction to serious injury.Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.3 blades were present on the balloon surface however the following blade damage was noted on one blade: blade 1: the blade was fully intact and bonded to the balloon.There was no issue with the balloon pad.Blade 2: proximal section of blade (approximately 5mm in length) detached and not returned.The full blade pad was intact.Blade 3: proximal section of blade (approximately 5mm in length) detached and not returned and 2mm of the distal section of the distal end of the blade detached and not returned.There was no issue with the balloon pad.A visual and tactile examination found that the hypotube was kinked at 19cm and 20cm distal to the strain relief.A visual and tactile examination found no damage along the shaft polymer extrusion.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.

• 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
• MDR Report Key: 12332547
• MDR Text Key: 266932022
• Report Number: 2134265-2021-10505
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2021

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: 04/03/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0027079409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/17/2021
• Supplement Dates Manufacturer Received: 08/20/2021; 09/24/2021
• Supplement Dates FDA Received: 09/02/2021; 10/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention