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 Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis.Visual and tactile inspection revealed no damage to the hypotube shaft profile, shaft polymer extrusion, or balloon.Microscopic analysis of the balloon showed no tears or pinholes, but traces of blood were present inside the balloon.All blades were fully bonded; the blades and the tip showed no signs of damage.The balloon was inflated to its rated burst pressure of 12 atmospheres and no leaks were noted.A microscopic examination of the proximal and distal markerbands showed the markerbands were not in their correct positions as per the material specification.The proximal markerband was positioned towards the distal markerband and the distal markerband had moved a little further distal on the inner.No damage was observed to either the proximal or distal markerband.In order to further examine the inner lumen where the markerbands are crimped, the ballon was cut.There was a very slight imprint on the inner where the proximal markerband was originally swaged in its correct position.The proximal markerband was not free moving; a slight tug test could not move the markerband.There were 2 markerband imprints on the inner, one between the two markerbands and another one at the supposed original position of the proximal markerband.A scratch mark was evident on the inner, presumably from the markerband movement.It was possible to insert a 0.015inch mandrel through the tip, inner/wire lumen with no resistance.This confirmed that there was no evidence of any significant stretching along the inner/wire lumen.

Event Description

It was reported that a markerband issue occurred.The target lesion was located in the left anterior descending artery (lad).A 10mmx3.75mm wolverine coronary cutting balloon was introduced over a 0.014 non-boston scientific (non-bsc) guidewire with no difficulty and no resistance encountered.When the device was exiting the 0.071 non-bsc guide catheter, x-ray fluoroscopy showed the balloon was shorter than 10mm.The issue had first been noted by the scrub nurse, but they thought they saw it wrong, so the physician was not aware until the balloon was seen on fluoroscopy.The device was immediately removed, and the procedure was successfully completed with another of the same device.There were no patient complications.After the case has been completed successfully, they looked further into detail and discovered that the proximal radiopaque marker was mounted in the wrong position.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18997812
• MDR Text Key: 338984005
• Report Number: 2124215-2024-13860
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/28/2024

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 Expiration Date: 06/06/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029545210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• 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: 0.014" ASAHI GUIDE WIRE; HEARTRAIL 0.071" GUIDE CATHETER