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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 M001103270
Device Problems Balloon; Detachment Of Device Component; Difficult to Remove ; Material Rupture; Catheter; Tip
Event Date 10/17/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that balloon rupture, removal difficulties and distal tip detachment occurred. The 90% stenosed, 20mm in length and 5. 0mm in diameter target lesion was located in the moderately tortuous vein in a forearm. A 4/4t/90 symmetry balloon catheter was advanced for pre-dilation. However, on the first inflation at 15 atmospheres, the balloon ruptured transversely after being inflated for 30 seconds. Upon attempt to withdraw the device the device could not be removed from the sheath and the distal tip of the device got detached and remained inside the patient's body. The sheath was then replaced with a 6f sheath and the detached tip was retrieved with the use of a snare device. No patient complications were reported and the patient's status was good.

 
Manufacturer Narrative

Device evaluated by mfr: a visual examination of the returned device identified that a complete circumferential tear had occurred in the balloon. The tear was located at 9mm distal to the proximal edge of the proximal balloon sleeve. The distal section of the balloon was trapped in a snare and pushed through a section of a 6french sheath. A break was evident in the shaft at 17mm proximal to the tip. An examination of the broken sections of the shaft identified that the shaft was severely stretched. This damage is consistent with excessive tensile force having been applied to the shaft. 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 balloon rupture, removal difficulties and distal tip detachment occurred. The 90% stenosed, 20mm in length and 5. 0mm in diameter target lesion was located in the moderately tortuous vein in a forearm. A 4/4t/90 symmetry¿ balloon catheter was advanced for pre-dilation. However, on the first inflation at 15 atmospheres, the balloon ruptured transversely after being inflated for 30 seconds. Upon attempt to withdraw the device the device could not be removed from the sheath and the distal tip of the device got detached and remained inside the patient's body. The sheath was then replaced with a 6f sheath and the detached tip was retrieved with the use of a snare device. No patient complications were reported and the 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 Key5217882
Report Number2134265-2015-07667
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/27/2018
Device MODEL NumberM001103270
Device Catalogue Number10-327
Device LOT Number17645447
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/26/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/29/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/06/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/11/2015 Patient Sequence Number: 1
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