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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 Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address 1: (b)(6).
 
Event Description
It was reported that a balloon removal difficulty occurred.The target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx2.25mm wolverine was selected for use.During the procedure, the balloon was inflated six times at 6-10atm for 5-6 seconds.Afterward, it was noted that the balloon could not be removed.The part of the lesion where the device got caught was dilated with another balloon and the device was removed.The procedure was completed with a different device.There were no patient complications reported.
 
Manufacturer Narrative
E1: initial reporter address 1: (b)(6).The wolverine cb mr, ous 10mmx2.25mm, catheter was returned for analysis.A visual and tactile examination of the hypotube identified multiple hypotube kinks at several locations along the hypotube shaft.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.Three blades were present on the balloon surface however blade damage was noted on one blade.The proximal blade segment of blade one was found to be lifted but still attached.No damage was noted with the pad of the blade, and it was fully adhered to the balloon material.No issues were noted with blades two and three.A visual and tactile examination identified inner shaft damage (stretching) approximately 5cm proximal to the distal tip.An examination of the tip section found no issues.A visual and microscopic examination found no issue with the marker bands.
 
Event Description
It was reported that a balloon removal difficulty occurred.The target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx2.25mm wolverine was selected for use.During the procedure, the balloon was inflated six times at 6-10atm for 5-6 seconds.Afterward it was noted that the balloon could not be removed.The part of the lesion where the device got caught was dilated with another balloon and the device was removed.The procedure was completed with a different device.There were no patient complications reported.The device was returned and analysis completed on 14jul2022.A visual and tactile examination of the hypotube identified multiple hypotube kinks at several locations along the hypotube shaft.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.3 blades were present on the balloon surface however the following blade damage was noted on one blade: blade 1: the proximal blade segment was found to be lifted but still attached.No damage was noted with the pad of the blade, and it was fully adhered to the balloon material.Blade 2: no issues noted.Blade 3: no issues noted.A visual and tactile examination identified inner shaft damage (stretching) approximately 5cm proximal to the distal tip.An examination of the tip section found no issues.A visual and microscopic examination found no issue with the marker bands.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14686634
MDR Text Key294049549
Report Number2134265-2022-06779
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/15/2022
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 Date11/25/2023
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0028449846
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/02/2022
Initial Date FDA Received06/14/2022
Supplement Dates Manufacturer Received07/14/2022
Supplement Dates FDA Received07/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/25/2021
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
6FR SHEATH- INTRODUCER SHEATH; 6FR SHEATH- INTRODUCER SHEATH; ASAHI INTEC SION- GUIDEWIRE; ASAHI INTEC SION- GUIDEWIRE; ASAHI INTEC- GUIDE CATHETER; ASAHI INTEC- GUIDE CATHETER
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