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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 Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2023
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual examination of the balloon identified no damages.The balloon was subjected to positive pressure and was in a deflated state.There were no issues noted with the hypotube shaft.A hole was noted on the inner and outer lumen of the shaft polymer extrusion, 5cm from tip of the device.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.When tracking a guidewire through the device, it pierced the side of the polymer extrusion causing damage to the inner and outer lumen.The tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.
 
Event Description
Reportable based on device analysis completed on 09oct2023.It was reported that it was not possible to inflate the balloon.A 10mmx3.25mm wolverine cutting balloon was selected for use.During the procedure, it was not possible to inflate the balloon properly.The procedure was completed with another of the same device.No patient complications resulted in relation to this event.However, device analysis revealed a hole in the polymer extrusion.
 
Event Description
Reportable based on device analysis completed on 09oct2023.It was reported that it was not possible to inflate the balloon.A 10mmx3.25mm wolverine cutting balloon was selected for use.During the procedure, it was not possible to inflate the balloon properly.The procedure was completed with another of the same device.No patient complications resulted in relation to this event.However, device analysis revealed a hole in the polymer extrusion.Upon further review of the investigation, it was realized that the hole occurred during product analysis and was not present on the device prior to functional testing during analysis.Based upon further review, it was determined that this event no longer meets the criteria of a reportable event.Inability to inflate the balloon events are not considered reportable as these events would not lead or might have led to death or serious deterioration in the state of health of a patient, user, or another person.These events are typically resolved by exchanging the device with minor prolongation or extension of the procedure beyond anticipated or expected duration (less than 10-minute delay).
 
Manufacturer Narrative
Device evaluated by mfr: a wolverine cutting balloon was returned to boston scientific corporation (bsc) for product analysis.A visual examination of the returned device was performed.The balloon was received in a deflated state indicating that it had been subjected to positive pressure (inflated) during use.There was a build-up of solidified blood in the balloon and inflation lumen, which is indicative of a leak in the device.No damage was visible on the balloon, and a detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All the blades were fully bonded on the balloon and no damage was identified.Examination found no anomalies or damage on the hypotube/shaft, tip of the device, or the markerbands.Functional testing of the device was performed, which included advancing a guidewire through the device.During advancement of the guidewire, friction was encountered, and the guidewire pierced through the inner and outer lumen of the shaft leaving a hole in the shaft approximately 5 cm from the tip of the device.Due to the hole in the shaft, bsc was not able to test balloon inflation during functional testing to identify the leak in the device.Based on the available information, the cause of the reported event (inability to inflate the balloon) could not be determined.
 
Event Description
Reportable based on device analysis completed on (b)(6) 2023.It was reported that it was not possible to inflate the balloon.A 10mmx3.25mm wolverine cutting balloon was selected for use.During the procedure, it was not possible to inflate the balloon properly.The procedure was completed with another of the same device.No patient complications resulted in relation to this event.However, device analysis revealed a hole in the polymer extrusion.Upon further review of the investigation, it was realized that the hole occurred during product analysis and was not present on the device prior to functional testing during analysis.Based upon further review, it was determined that this event no longer meets the criteria of a reportable event.Inability to inflate the balloon events are not considered reportable as these events would not lead or might have led to death or serious deterioration in the state of health of a patient, user, or another person.These events are typically resolved by exchanging the device with minor prolongation or extension of the procedure beyond anticipated or expected duration (less than 10-minute delay).
 
Manufacturer Narrative
Correction: b5: describe event or problem: added new information.H6: evaluation result codes: updated from 'stress problem identified" to 'operational problem identified'.H6: evaluation conclusion codes: updated 'unintended use error caused or contributed to event' to cause not established.H10: replaced previously provide investigation with corrected investigation.Device evaluated by mfr: a wolverine cutting balloon was returned to boston scientific corporation (bsc) for product analysis.A visual examination of the returned device was performed.The balloon was received in a deflated state indicating that it had been subjected to positive pressure (inflated) during use.There was a build-up of solidified blood in the balloon and inflation lumen, which is indicative of a leak in the device.No damage was visible on the balloon, and a detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All the blades were fully bonded on the balloon and no damage was identified.Examination found no anomalies or damage on the hypotube/shaft, tip of the device, or the markerbands.Functional testing of the device was performed, which included advancing a guidewire through the device.During advancement of the guidewire, friction was encountered, and the guidewire pierced through the inner and outer lumen of the shaft leaving a hole in the shaft approximately 5 cm from the tip of the device.Due to the hole in the shaft, bsc was not able to test balloon inflation during functional testing to identify the leak in the device.Based on the available information, the cause of the reported event (inability to inflate the balloon) could not be determined.Additional testing by manufacture: upon further additional testing, a liquid leaked out through the puncture site in the extrusion during an attempt to inflate the balloon.This prevented the balloon from inflating.Following an attempt to plug the puncture site, it was noted that the balloon could inflate, however the balloon could not maintain its rated burst pressure due to the puncture site in the lumen.
 
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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 Key18022024
MDR Text Key327750576
Report Number2124215-2023-59968
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0030622451
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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