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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYMMETRY¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC - GALWAY SYMMETRY¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number M001103340
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/22/2015
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Event Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in a shunt of the left forearm.A non bsc guide wire crossed the lesion, then a 6.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, it was noted that there was something like a 'crack' on the proximal shaft of the device and during inflation, the balloon was unable to be inflated.The device was removed from the non bsc sheath and was exchanged to 5.0-40/4t/90 symmetry standard balloon to complete the procedure.No patient complications were reported and patient's status was good.
 
Manufacturer Narrative
Device evaluated by mfr: a symmetry balloon dilation catheter was received for analysis.A visual and microscopic examination found no issues with the tip section of the device.A visual examination of the balloon confirmed that the balloon had been subjected to positive pressure.The balloon was fully detached from the shaft and it was visually noted that there was blood in the balloon which is indicative of a leak.The shaft was broken immediately proximal to the proximal end of the balloon.A visual and tactile examination found that the proximal end of the shaft was kinked along its length.This type of damage is consistent with the application of excessive force.The shaft outer diameter (od) was measured at an undamaged portion of the shaft which is within specification.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that shaft break occurred.The 90% stenosed target lesion was located in a shunt of the left forearm.A non bsc guide wire crossed the lesion, then a 6.0-4/4t/90 symmetry balloon catheter was advanced for dilatation.However, it was noted that there was something like a 'crack' on the proximal shaft of the device and during inflation, the balloon was unable to be inflated.The device was removed from the non bsc sheath and was exchanged to 5.0-40/4t/90 symmetry standard balloon to complete the procedure.No patient complications were reported and patient's status was good.
 
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Brand Name
SYMMETRY¿
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5011679
MDR Text Key23393300
Report Number2134265-2015-05414
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K953602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Followup
Report Date 07/23/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/19/2017
Device Model NumberM001103340
Device Catalogue Number10-334
Device Lot Number0017378956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/29/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2014
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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