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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 09/06/2023

Event Type  Injury  

Event Description

It was reported that a dissection occurred.The patient presented for a percutaneous transluminal coronary angioplasty (ptca).The 90% stenosed lesion was located in a mildly tortuous and moderately calcified mid eft anterior descending artery (lad).The lesion was not pre-dilated with 2.50 x 12 mm non-complaint balloon.The target lesion was fibrotic, hence a 3.00 x 10 wolverine balloon used for the vessel preparation.A 3.00 x 10 wolverine balloon used to dilate the lesion at 12 atmospheres from left main (lm) to mid lad.Then, a 3.50 x 20 mm synergy stent tried to deploy the stent, but the catheter failed cross the distal lesion.The device removed with the stent from the patient, and it was noted the stent strut damaged.Then, the lesion was dilated with wolverine balloon at 18 atmospheres for two to three cycles in preferential method.Since, imaging was not there, the physician assumed that a distal mild dissection occurred.The procedure was completed with 3.50 x 24 mm synergy stent.A 4.00 x 8.00 mm non-complaint balloon was used to post dilate the lm.There were no further patient complications reported.Post procedure, the patient was safe.

• 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: 17827672
• MDR Text Key: 324396602
• Report Number: 2124215-2023-52077
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: Asian