• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Perforation of Vessels (2135)
Event Date 08/01/2023
Event Type  Injury  
Event Description
It was reported that a perforation occurred requiring additional intervention.The patient presented with a subacute anterior myocardial infarction.Coronary angiogram revealed 50% stenosis with severe calcification of the left main coronary artery (lmt) and 90% stenosis with severe calcification of the left anterior descending artery (lad).The target lesion, located in the lad, was debulked using rotational atherectomy as intravascular ultrasound (ivus) was unable to be performed.A 1.50mm burr was selected, followed by additional debulking with a 1.75mm burr.Pre-dilation of the lesion was completed using a 2.50 mm wolverine cutting balloon.Balloon indentation disappeared and a contrast leakage was then observed from the proximal lad.In an attempt to establish homeostasis, a 2.50 mm non-scientific balloon was introduced with multiple extended inflations, but homeostasis was unable to be achieved.A 2.50 x 10 mm non-boston scientific stent was then deployed in the lad, but bleeding continued.Ivus showed a disruption in the vessel wall due to a crack in the calcification of the distal lmt, evidencing a hemorrhage from the same area via the adventitia.A 3.00 x 15 mm non-boston scientific stent was deployed in the lmt to lad, but homeostasis was not achieved.Finally, a 3.00 x 20 mm non-boston scientific covered stent was deployed over the previous stent, occluding the left circumflex.Homeostasis was successfully achieved after difficulty locating the perforation site.
 
Manufacturer Narrative
B3 date of event was estimated based on aware date as no event date was provided."mp29-8_a case of lmt perforation with difficult hemostatic site identification and hemostasis," was on a poster presentation at a conference held on friday, august 4, 2023 in fukuoka, japan.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
WOLVERINE CORONARY CUTTING BALLOON
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
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17705481
MDR Text Key322924778
Report Number2124215-2023-48850
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 09/07/2023
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? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/07/2023
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 Number1
Treatment
2.5MM RYUSEI BALLOON; 2.5MM/10MM PK PAPYRUS; 3.0MM/15MM XIENCE SKYPOINT; 3.0MM/20MM PK PAPYRUS
Patient Outcome(s) Required Intervention;
Patient Age88 YR
Patient SexFemale
-
-