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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 24658
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2022
Event Type  malfunction  
Event Description
It was reported that a catheter separation occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified below the knee artery.A 4.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During procedure, the device was pulled out from the hoop without any resistance.However, a catheter separation at about 20cm from the tip of the shaft was noted outside the patient's body.The procedure was completed with another of the same device and there was no patient injury reported.
 
Event Description
It was reported that a catheter separation occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified below the knee artery.A 4.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During procedure, the device was pulled out from the hoop without any resistance.However, a catheter separation at about 20cm from the tip of the shaft was noted outside the patient's body.The procedure was completed with another of the same device and there was no patient injury reported.
 
Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.The device was returned with the balloon protector partially removed from the balloon which is evidence that an attempt was made to remove the protector from the device.For investigation purposes the investigator fully removed the protector without issue.A visual examination identified that the balloon was not subjected to positive pressure.The balloon material and blades of the device were visually examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were fully bonded to the balloon material.The device was received with the balloon protector partially removed from the device.The investigator was unable to apply a vacuum to the device as per preparation instructions indicated in spcb ifu due to a shaft break.For investigation purposes the investigator removed the balloon protector without issue.The balloon protectors' inner diameter was verified at 0.0435 inch using a calibrated pin gauge.This is within the specified range of specification.A visual investigation identified no damage or any issues with the markerbands of the device that could have contributed to the complaint incident.This concludes the product analysis.
 
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Brand Name
SMALL PERIPHERAL CUTTING BALLOON
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15908154
MDR Text Key305892832
Report Number2124215-2022-49901
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 01/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/03/2023
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0026292392
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2020
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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