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); Failure to Advance (2524); Material Deformation (2976)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 18dec2023.It was reported that the catheter could not cross the lesion and was kinked.The target lesion was located in the left anterior descending artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon could not cross the lesion during the advancing.Furthermore, the cutting balloon was kinked and could not be used as normal.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, device analysis revealed that a total of 83.2cm from the tip of the device to the hypotube break was received.

Manufacturer Narrative

E1 - initial reporter address 1:(b)(6).Device evauated by mfr.: the device was returned for analysis.The proximal section of the device was returned.The manifold was not returned.A visual examination of the balloon identified no damages.A hypotube break was identified.A total of 83.2cm from the tip of the device to the hypotube break was received.No kinks or damages in the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.A hypotube break was identified.A total of 83.2cm from the tip of the device to the hypotube break was received.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during examination of the extrusion shaft.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the catheter could not cross the lesion and was kinked.The target lesion was located in the left anterior descending artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon could not cross the lesion during the advancing.Furthermore, the cutting balloon was kinked and could not be used as normal.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, device analysis revealed that a total of 83.2cm from the tip of the device to the hypotube break was received.It was further reported that the shaft break occurred during the procedure.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.The proximal section of the device was returned.The manifold was not returned.A visual examination of the balloon identified no damages.A hypotube break was identified.A total of 83.2cm from the tip of the device to the hypotube break was received.No kinks or damages in the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.A hypotube break was identified.A total of 83.2cm from the tip of the device to the hypotube break was received.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during examination of the extrusion shaft.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• 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: 18428878
• MDR Text Key: 332260526
• Report Number: 2124215-2023-74769
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0030958560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 70 KG