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 Entrapment of Device (1212)

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

It was reported that the balloon was stuck with the wire.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery (sfa).A 4.0mm x 15mm wolverine cutting ballon was selected for use.During the procedure, an attempt was made to dilate the significant stenosis using wolverine.However, it got stuck during delivery into the lesion.The balloon's wire lumen and wire probably got stuck, and the device was unable to push the balloon forward alone.There seemed to be no resistance between the balloon and the blood vessels.Therefore, both the non-boston scientific guidewire and wolverine were removed, and the use was discontinued.Furthermore, the device was unable to remove the product alone, so the device was removed it along with the wire probably because the balloon's wire lumen and wire are stuck for some reason.The lesion was then crossed again using another non-boston scientific device, and the lesion was dilated using the wolverine 4.0mm of another lot.The device was completely removed from the patient and the procedure was completed with another of the same device.There were no patient complications reported and the patient was stable after the procedure.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The device was received advanced on to the customer's guidewire.This wolverine device is recommended for use with a 0.014 inch (0.36mm) guidewire as per specifications.During the product analysis, the device was unable to be removed from the customer's guidewire due to damage to the shaft polymer extrusion of the returned device.The guidewire used by the customer was measured using a calibrated snap gauge and was confirmed to be 0.014 inch.A visual examination identified that the shaft polymer extrusion of the device was severely buckled along the entire length.This type of damage is consistent with the user applying excessive force to the device.No other issues were identified with the shaft of the device.A visual examination found no issues or damage to the balloon, blades, markerbands or tip of the returned device.The balloon had not been inflated.

Event Description

It was reported that the balloon was stuck with the wire.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery (sfa).A 4.0mm x 15mm wolverine cutting ballon was selected for use.During the procedure, an attempt was made to dilate the significant stenosis using wolverine.However, it got stuck during delivery into the lesion.The balloon's wire lumen and wire probably got stuck, and the device was unable to push the balloon forward alone.There seemed to be no resistance between the balloon and the blood vessels.Therefore, both the non-boston scientific guidewire and wolverine were removed, and the use was discontinued.Furthermore, the device was unable to remove the product alone, so the device was removed it along with the wire probably because the balloon's wire lumen and wire are stuck for some reason.The lesion was then crossed again using another non-boston scientific device, and the lesion was dilated using the wolverine 4.0mm of another lot.The device was completely removed from the patient and the procedure was completed with another of the same device.There were no patient complications reported and the patient was stable after the procedure.

• 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: 18861701
• MDR Text Key: 337665471
• Report Number: 2124215-2024-11666
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: 0032420558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2023
• 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 Sex: Female