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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number 24630
Device Problem Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis. A visual and microscopic examination was identified no issues or damage to the blades of the returned device. All blades were undamaged and fully bonded to the balloon material. An examination of the returned device identified that the balloon had been inflated. Blood was noted inside the device which is evidence of a device leak. The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied in an attempt to inflate the balloon. The balloon could not be inflated due to the presence of a shaft leak. A microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint. No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident. A visual and tactile examination identified a severe kinking at more than one location on the shaft of the device. This type of damage is consistent with excessive force being applied to the device. During analysis the returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon and liquid was observed exiting from the site of one of the severe shaft kinks located at the proximal balloon bond. No other issues were noted with the shaft of the device. No other issues were identified during the product analysis.
 
Event Description
Reportable based on device analysis completed on 17dec2020. It was reported that there was a device performance issue with the 7. 00mm / 2. 0cm / 90cm peripheral cutting balloon. The procedure was successfully completed with another peripheral cutting balloon. There were no patient complications reported and the patient was fine. However, device analysis found a shaft leak.
 
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Brand Name2CM PERIPHERAL CUTTING BALLOON
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11151381
MDR Text Key226265198
Report Number2134265-2020-18885
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/16/2022
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0025725273
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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