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

Model Number 39345-401510

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 05/15/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter address: (b)(6).

Event Description

It was reported that the blade was partially lifted.Vascular access was obtained via brachial artery approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, the target lesion was dilated using shiden hp4x150.Since sfa periphery has insufficient dilation, the lesion was dilated three time using this device, but the balloon could not reach the complete dilation.Subsequently, dilation was performed with shiden hp5x150, and the previous insufficient dilated parts were dilated.After removal, the blade was found to be bent when it was put into the hoop.After the case, the physician in charge checked thoroughly the blade, and it was unable to confirm that the blade got dislodged.Also, there was something that was peeling off from the balloon.It looked soft like resin and does not seem to be the blade.The procedure was completed with this device.No patient complications reported.

Event Description

It was reported that the blade was partially lifted.Vascular access was obtained via brachial artery approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, the target lesion was dilated using shiden hp4x150.Since sfa periphery has insufficient dilation, the lesion was dilated three time using this device, but the balloon could not reach the complete dilation.Subsequently, dilation was performed with shiden hp5x150, and the previous insufficient dilated parts were dilated.After removal, the blade was found to be bent when it was put into the hoop.After the case, the physician in charge checked thoroughly the blade, and it was unable to confirm that the blade got dislodged.Also, there was something that was peeling off from the balloon.It looked soft like resin and does not seem to be the blade.The procedure was completed with this device.No patient complications reported.

Manufacturer Narrative

E1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination was performed on the returned device, and it was noted that approximately 5mm of the proximal end of one of the blades and pad was lifted distally from the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon was not folded, which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 12 atmospheres for 30 seconds using digital timer: g24610, without issue.A vacuum was then applied.The inflation device was verified at 12 atmospheres, before and after use with calibrated pressure gauge g19252.This inflation to rate of burst pressure of 12 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per wolverine pi eifu the rated burst pressure for this device is 12 atmospheres.No issue was observed with the tip or markerbands of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.

• Brand Name: WOLVERINE PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17059894
• MDR Text Key: 316516506
• Report Number: 2124215-2023-28347
• 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: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 39345-401510
• Device Catalogue Number: 39345-401510
• Device Lot Number: 0030114607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• 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: BALLOON CATHETER- SHIDEN; BALLOON CATHETER- SHIDEN; GUIDEWIRE- CORDIS VASALLO GT NS3; GUIDEWIRE- CORDIS VASALLO GT NS3; SHEATH- TERUMO DESTINATION 6FR90CM; SHEATH- TERUMO DESTINATION 6FR90CM