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

Model Number 3852

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/02/2024

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).

Event Description

It was reported that the device was fractured.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery (lad).A 15mmx2.50mm wolverine cutting balloon was selected for use.Upon packing, the balloon catheter was found to be fractured 123.5cm from the shaft.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.

Event Description

It was reported that the device was fractured.The 80% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery (lad).A 15mmx2.50mm wolverine cutting balloon was selected for use.Upon packing, the balloon catheter was found to be fractured 123.5cm from the shaft.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.

Manufacturer Narrative

E1: initial reporter facility name: beijing wangfu hospital of integrated traditional chinese and western medicine e1: initial reporter address 1: no.1, (b)(6), beijing device evaluated by mfr.: the device was returned for analysis.A visual and tactile examination of the hypotube shaft identified no issues.A visual and tactile examination of the outer and inner lumen and mid-shaft section found a break.Additionally, polymer extrusion damage was noted.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Examination of the outer and inner lumen and mid-shaft section found a break at the of the guidewire exchange port.Additionally, the inner lumen was noted to be bunched at 5.1cm from the tip of the device.Bumper tip showed no signs of distal tip 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: 19013124
• MDR Text Key: 339036360
• Report Number: 2124215-2024-19320
• 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: 04/15/2024

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: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0030548216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2022
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 75 KG