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 Material Rupture (1546)

Patient Problem Perforation (2001)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

Information was obtained from the topic 2019 conference held on july 12.Age at time of event: 90 years.Date of event is an estimated date based off the aware date as the exact event date was not reported.

Event Description

It was reported at a conference that balloon rupture and perforation had occured.The patient presented with unstable angina.The 90% stenosed target lesion was located in a severely calcified proximal left anterior descending artery.A coronary artery perforation was noted after a wolverine coronary cutting balloon monorail ruptured at a high pressure and was removed without any difficulties.A 3 mm perfusion balloon catheter was used to arrest hemorrhage.The hemostate was confirmed on the image so an unspecified stent was deployed to cover the dissection.However, it was bleeding again.Although a 2.8 x 19 mm graft was deployed and a 3.5 mm balloon catheter was used, the physician was not able to arrest hemorrhage.Finally a 4 mm perfusion balloon catheter was used to arrest hemorrhage.No further patient complications were reported and the patient was stable.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8860507
• MDR Text Key: 153255169
• Report Number: 2134265-2019-09193
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Initial Date Manufacturer Received: 07/12/2019
• Initial Date FDA Received: 08/05/2019
• 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
• Treatment: STENT - GRFT MASTER 2.8X19MM
• Patient Outcome(s): Required Intervention