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

Model Number 3851

Device Problem Material Rupture (1546)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the balloon ruptured.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified first right posterolateral segment of the right coronary artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon ruptured upon first inflation at 6 atmospheres for 5 seconds and a slit was noted.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with another of the same device.No complications were reported and the patient was in good condition after the procedure.

Manufacturer Narrative

E1 - initial reporter address: (b)(6).

Event Description

It was reported that the balloon ruptured.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified first right posterolateral segment of the right coronary artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon ruptured upon first inflation at 6 atmospheres for 5 seconds and a slit was noted.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with another of the same device.No complications were reported and the patient was in good condition after the procedure.It was further reported that the first wolverine device used had the blade 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: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon wings were in a deflated state and had been subjected to positive pressure.A microscopic examination of the balloon found no tears or holes in the balloon material.The device was attached to a boston scientific encore inflation unit and during an attempt to inflate the balloon a pinhole leak confirmed.The pinhole leak was confirmed in the mid-body of the balloon.The blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.A visual and tactile examination found no kinks or damages on hypotube/shaft.No issues were noted with the tip section of the device.

Event Description

It was reported that the balloon ruptured.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified first right posterolateral segment of the right coronary artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon ruptured upon first inflation at 6 atmospheres for 5 seconds and a slit was noted.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with another of the same device.No complications were reported and the patient was in good condition after the procedure.It was further reported that the first wolverine device used had the blade 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.

• 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: 12358763
• MDR Text Key: 267836378
• Report Number: 2134265-2021-10739
• 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: 10/05/2021

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: 05/27/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0027391955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 08/11/2021; 09/17/2021
• Supplement Dates FDA Received: 09/02/2021; 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention