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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number M001BP35620B0
Device Problems Cutter/Blade (777); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/23/2015
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older (b)(4).

 
Event Description

It was reported that the blade was about to detach. The vascular access was obtained via the left femoral artery with retrograde approach. The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left external iliac artery (eia). A 6. 00mmx2. 0cmx135cm peripheral cutting balloon was used to treat the target lesion. Dilation was performed in two locations at 6atm for 30 seconds. When the balloon catheter was started to be withdrawn in the sheath, a small resistance was encountered. The balloon catheter was carefully removed from the patient and it was noted that the blade was about to detach after checking it outside the patient. The procedure was completed with a different device. No patient complications were reported and the patient's condition was good.

 
Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis. A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure. Solidified contrast media was identified within the balloon. A microscopic examination identified that approximately 6mm of the proximal end of a blade and blade pad were lifted from the balloon; however, no section was detached. Approximately 4mm of the proximal end of the blade pad was still intact. A microscopic examination observed no damage to the additional blades. These blades were present and fully bonded to the balloon surface. No damage was noted to the tip or balloon of the device. During analysis, the device was attached to an encore inflation unit. The balloon was unable to be completely deflated prior to insertion through the recommended size 7fr sheath as identified on the product label due to the solidified contrast media within the balloon. The device was soaked in a water bath at 37 degrees to help soften the solidified contrast media. After soaking, a vacuum was pulled for balloon preparation and the catheter was advanced through the sheath and positive pressure was applied. The balloon was able to be inflated to its rated burst pressure of 10 atmospheres and maintained pressure with no leaks noted. The encore inflation unit was verified before and after use using a calibrated pressure gauge. The device was deflated and removed through the sheath without issue. No kinks or damage were noticed along the shaft of the device. It is possible that resistance between the device and sheath could potentially have resulted in part of the blade getting caught on the introducer sheath and lifting from the balloon. 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 the blade was about to detach. The vascular access was obtained via the left femoral artery with retrograde approach. The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left external iliac artery (eia). A 6. 00mmx2. 0cmx135cm peripheral cutting balloon¿ was used to treat the target lesion. Dilation was performed in two locations at 6atm for 30 seconds. When the balloon catheter was started to be withdrawn in the sheath, a small resistance was encountered. The balloon catheter was carefully removed from the patient and it was noted that the blade was about to detach after checking it outside the patient. The procedure was completed with a different device. No patient complications were reported and the patient's condition was good.

 
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Brand Name2CM PERIPHERAL CUTTING BALLOON¿
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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 Key5021762
MDR Text Key23720328
Report Number2134265-2015-05949
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
PMA/PMN NumberK070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
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 Received08/21/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/10/2016
Device MODEL NumberM001BP35620B0
Device Catalogue NumberBP1356020B
Device LOT Number0017533891
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/28/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/22/2014
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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