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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 Problems Shaft; Break
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 NameSYMMETRY¿
Type of DeviceCATHETER, 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
Report Number2134265-2015-05414
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/23/2015
1 Device Was Involved in the Event
0 PatientS WERE 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
Was the Report Sent to FDA?
Event Location No Information
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

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