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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 M001BP50520B0
Device Problems Balloon (419); Cutter/Blade (777); Detachment Of Device Component (1104); Difficult to Remove (1528); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/14/2015
Event Type  Malfunction  
Event Description

It was reported that the blade lifted and became detachment. Vascular access was obtained from the same side of the lesion utilizing anterograde approach. The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel in the left forearm. After crossing a 100cm non-bsc guide wire to the lesion, the 5. 00mmx2. 0cmx50cm peripheral cutting balloon¿ was delivered and dilatation was performed twice. A 7fr non-bsc sheath was used together and deflation was performed slowly at 16 atm for 5 seconds. The balloon was used without issue, however when withdrawal was attempted, small resistance was encountered. The balloon was then advanced from the distal section of the sheath and was slightly inflated and then deflated slowly. The balloon was then retracted into the sheath without issue and was removed from the patient. The device was checked outside of the patient and it was noted that one of the blade was lifted and detached. It was thought that no parts of the device fall into the patient. The procedure was completed with this device. No patient complications were reported and the patient's condition was good.

 
Manufacturer Narrative

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

 
Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis. A visual examination of the device found that the returned balloon had evidence of being inflated and blood was identified within the balloon and inflation lumen. Blood within the balloon or inflation lumen is evidence of a device leak. A microscopic examination identified that approximately 6 mm of the proximal end of a blade and pad had detached from the balloon. 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 of the device. No kinks or damage were noticed along the shaft of the device. During analysis, the device was connected to an encore inflation unit and a vacuum was pulled for balloon preparation prior to advancement through the recommended size introducer sheath as identified on the product label. The device was inserted over a 0. 018 inch guidewire and through a 7fr introducer sheath without issue. Positive pressure was applied when liquid was observed to be leaking from a pinhole in the balloon material at 3 mm distal to the distal of the proximal markerband. 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 lifted and became detachment. Vascular access was obtained from the same side of the lesion utilizing anterograde approach. The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel in the left forearm. After crossing a 100cm non-bsc guide wire to the lesion, the 5. 00mmx2. 0cmx50cm peripheral cutting balloon was delivered and dilatation was performed twice. A 7fr non-bsc sheath was used together and deflation was performed slowly at 16 atm for 5 seconds. The balloon was used without issue, however when withdrawal was attempted, small resistance was encountered. The balloon was then advanced from the distal section of the sheath and was slightly inflated and then deflated slowly. The balloon was then retracted into the sheath without issue and was removed from the patient. The device was checked outside of the patient and it was noted that one of the blade was lifted and detached. It was thought that no parts of the device fall into the patient. The procedure was completed with this 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
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4837791
MDR Text Key5938011
Report Number2134265-2015-03572
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 Foreign,Health Professional,Company Representative,Distributor,COMPANY REPRESENT
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/11/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/01/2017
Device MODEL NumberM001BP50520B0
Device Catalogue NumberBP505020B
Device LOT Number0017659949
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/18/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/13/2015
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: 06/11/2015 Patient Sequence Number: 1
Treatment
GUIDEWIRE: GT016 100CM TERUMO; BALLOON CATHETER: PCB2CM OTW 5.0-20/4.2/50
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