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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 3850
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2023
Event Type  malfunction  
Event Description
It was reported that the device was contaminated.A 6mmx2.00mm wolverine coronary cutting balloon was selected for use in the left anterior descending artery.During the procedure, the device fell on the ground when it was taken out causing the sterility of the device compromised and could not be used.There were no punctures in the packaging, but sealing port problem was suspected.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual and microscopic examination identified that the balloon was folded.No damage was observed along the entire balloon.There was no evidence of device use.All blades were intact within their pads and fully bonded to the balloon material.A visual and microscopic and tactile examinations identified no kinks or damages.A visual and tactile examination of the distal extrusion identified no damage.The markerbands were visually and microscopically examined, and no issues were noted.An examination of the tip section of the device identified no damage.No device packaging was received in order to inspect the packaging seals.However, a similar complaint review was performed into this particular batch of device and it was confirmed that there were no other similar complaints reporting any allegation regarding the package seals.
 
Event Description
It was reported that the device was contaminated.A 6mmx2.00mm wolverine coronary cutting balloon was selected for use in the left anterior descending artery.During the procedure, the device fell on the ground when it was taken out causing the sterility of the device compromised and could not be used.There were no punctures in the packaging, but sealing port problem was suspected.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post 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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key16950461
MDR Text Key315446697
Report Number2124215-2023-22916
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3850
Device Catalogue Number3850
Device Lot Number0030819205
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2023
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 Age65 YR
Patient SexMale
Patient Weight76 KG
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