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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3851
Device Problems Break (1069); Difficult to Remove (1528); Failure to Deflate (4060)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/28/2023
Event Type  Death  
Event Description
It was reported that failure to deflate device, device detachment and patient death occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for a percutaneous coronary intervention procedure.The area of treatment was located in the proximal circumflex artery.A nc balloon was used to dilate the stenosis within the lesion.The nc balloon did not successfully dilate the stenosed lesion.The 10mmx3.00mm wolverine coronary cutting balloon was then advanced and post dilation it was observed that the balloon did not fully deflate.The 10mmx3.00mm wolverine coronary cutting balloon was then moved forward then backwards.The catheter detached from the balloon.The catheter was removed from the balloon and the balloon remained in the vessel.A buddy wire with a second balloon was used to dilate the vessel and to remove the wolverine but was not successful.A snare was used to retrieve the detached balloon but was not successful.The patient was not stable and patient death occurred.
 
Manufacturer Narrative
E1: initial reporter phone number - (b)(6).
 
Event Description
It was reported that failure to deflate device, device detachment and patient death occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for a percutaneous coronary intervention procedure.The area of treatment was located in the proximal circumflex artery.A nc balloon was used to dilate the stenosis within the lesion.The nc balloon did not successfully dilate the stenosed lesion.The 10mmx3.00mm wolverine coronary cutting balloon was then advanced and post dilation it was observed that the balloon did not fully deflate.The 10mmx3.00mm wolverine coronary cutting balloon was then moved forward then backwards.The catheter detached from the balloon.The catheter was removed from the balloon and the balloon remained in the vessel.A buddy wire with a second balloon was used to dilate the vessel and to remove the wolverine but was not successful.A snare was used to retrieve the detached balloon but was not successful.The patient was not stable and patient death occurred.It was further reported that the lesion was within the circumflex artery.The wolverine coronary cutting balloon fractured 10cm from the device tip.
 
Manufacturer Narrative
E1: initial reporter phone number - (b)(6).The device was not returned for analysis.Procedural angiographic media was provided to assist in the investigation and was reviewed by a boston scientific medical director.Media review identified that a previously placed stent had been placed and a distal stent strut was lifted.The final review noted the following: this case was a high risk, ivus-guided coronary intervention to treat in-stent restenosis in a previously stented lmt bifurcation.The media reviewed are consistent with cutting balloon entanglement with a previously placed stent as the primary issue.Excessive manipulation while positioning the cutting balloon may have caused hypotube damage or entanglement with the previously placed stent.Hypotube damage may have contributed to incomplete balloon expansion or incomplete evacuation of the inflation media during deflation.The inability to completely deflate the balloon did not appear to trap an expanded balloon in the vessel; however, the incompletely deflated balloon did obstruct blood flow through the vessel.Severe ischemia resulted when the partially deflated balloon obstructed the left coronary artery.Continued effort to remove the stuck wolverine catheter resulted in device separation with an irretrievable device fragment lodged in the lmt bifurcation.Preparation for emergency percutaneous mechanical circulatory support ensued but ultimately the patient did not survive.The cutting balloon may have become entrapped by the lifted stent strut leading to withdrawal difficulty.Severe (global) myocardial ischemia caused by lmt obstruction from the device fragment likely contributed greatly to the fatal outcome.
 
Event Description
It was reported that failure to deflate device, device detachment and patient death occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for a percutaneous coronary intervention procedure.The area of treatment was located in the proximal circumflex artery.A nc balloon was used to dilate the stenosis within the lesion.The nc balloon did not successfully dilate the stenosed lesion.The 10mmx3.00mm wolverine coronary cutting balloon was then advanced and post dilation it was observed that the balloon did not fully deflate.The 10mmx3.00mm wolverine coronary cutting balloon was then moved forward then backwards.The catheter detached from the balloon.The catheter was removed from the balloon and the balloon remained in the vessel.A buddy wire with a second balloon was used to dilate the vessel and to remove the wolverine but was not successful.A snare was used to retrieve the detached balloon but was not successful.The patient was not stable and patient death occurred.It was further reported that the lesion was within the circumflex artery.The wolverine coronary cutting balloon fractured 10cm from the device tip.
 
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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
boston scientific
ireland limited
galway
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16467596
MDR Text Key310511885
Report Number2124215-2023-09616
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3851
Device Catalogue Number3851
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age81 YR
Patient Weight56 KG
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