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 Failure to Advance (2524)

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

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination of the hypotube shaft identified a break at 53.5cm distal to the distal end of the strain relief.Hypotube kinks were also noted.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.There was no sign of damage, stretching or lifting of the stent struts.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube shaft identified a break at 53.5cm distal to the distal end of the strain relief.Multiple hypotube kinks were also noted in various locations along the length of the hypotube shaft.Bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.

Event Description

Reportable based on device analysis completed on (b)(6) 2024.It was reported that balloon was unable to cross the lesion.The diffused stenosed target lesion was located in the proximal-middle left anterior descending artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During procedure, pre-dilation was performed using a 20x20mm non-boston scientific balloon to proximal end of the pd and proximal-middle end of the lesion.After repeated dilatation under the condition of 8-16atm for 10sec, the dilatation was poor.This device was then delivered to the proximal-middle end of the lesion in the right coronary artery.However, after repeated attempts, it could not reach the lesion, so they replaced it with the another of same device and completed the procedure.No complications reported and patient was stable post procedure.However, device analysis revealed a hypotube break.

• 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: 18979325
• MDR Text Key: 339212134
• Report Number: 2124215-2024-17744
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

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: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0031194705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 68 KG