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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYMMETRY; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION SYMMETRY; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 23295
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel.A 6.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at 16 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a moderately tortuous and moderately calcified vessel.A 6.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, during the first inflation at 16 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
E1 - initial reporter address: (b)(6).E1 - initial reporter city: (b)(6).Device evaluated by mfr: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.A microscopic examination identified a balloon longitudinal tear beginning approximately 5mm proximal of the proximal markerband and extending approximately 10mm distally across the balloon material.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this balloon is 15 atmospheres.A visual and tactile examination identified no damage or issues with the shaft of the device.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.No other issues were identified during the product analysis.
 
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Brand Name
SYMMETRY
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9515013
MDR Text Key176781150
Report Number2134265-2019-16119
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729181972
UDI-Public08714729181972
Combination Product (y/n)N
PMA/PMN Number
K143193
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 02/25/2020
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 Date02/26/2022
Device Model Number23295
Device Catalogue Number23295
Device Lot Number0023410624
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2020
Initial Date Manufacturer Received 12/16/2019
Initial Date FDA Received12/24/2019
Supplement Dates Manufacturer Received02/05/2020
Supplement Dates FDA Received02/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDE WIRE: KYOUSHANT18; GUIDE WIRE: KYOUSHANT18; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INFLATION DEVICE: FUJI MEDICAL INDEFLATOR; INTRODUCER SHEATH: TERUMO 5FR; INTRODUCER SHEATH: TERUMO 5FR
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