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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 Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the balloon ruptured.The 90% stenosed target lesion area was located in a mildly tortuous and severely calcified distal right coronary artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, it was noted that balloon was inflated multiple times for 10 seconds before it ruptured at 12 atmospheres.The device was able to be removed and the procedure was completed with another of the same device.There were no complications reported and the patient is in good condition after the procedure.
 
Manufacturer Narrative
E1.Initial reporter city: (b)(6).Wolverine cb mr, ous 10mmx2.50mm balloon delivery system was returned for analysis.A visual examination of the balloon identified blood inside the balloon.This blood is consistent with a leak having occurred in the device.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied to inflate the balloon however, the balloon failed to inflate.The failure to inflate the balloon is consistent with the build-up of solidified blood in the device.As a result, the device was soaked at 37 degress celsius in a watherbath in an attempt to dissolve the solidified blood.A second attempt was later performed at inflating the balloon when a pinhole leak of liquid was observed to be leaking from the balloon.The pinhole leak was located in the mid-section of the balloon.An examination of the balloon material identified no issues with the balloon which could have contributed to the pinhole leak.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and tactile examination found no issues with the shaft of the device which may have potentially contributed to the reported incident.No shaft kinks were noted at the distal end of the tip.No other issues were identified during the product analysis.
 
Event Description
It was reported that the balloon ruptured.The 90% stenosed target lesion area was located in a mildly tortuous and severely calcified distal right coronary artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, it was noted that balloon was inflated multiple times for 10 seconds before it ruptured at 12 atmospheres.The device was able to be removed and the procedure was completed with another of the same device.There were no complications reported and the patient is in good condition after the procedure.
 
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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
two scimed place
maple grove MN 55311
MDR Report Key10986101
MDR Text Key220763905
Report Number2134265-2020-17232
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 01/14/2021
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 Expiration Date08/31/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0025943587
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2020
Initial Date Manufacturer Received 12/01/2020
Initial Date FDA Received12/10/2020
Supplement Dates Manufacturer Received01/06/2021
Supplement Dates FDA Received01/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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