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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 M001BP50620B0
Device Problems Balloon; Cutter; Detachment Of Device Component; Difficult to Remove
Event Date 10/14/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that difficulty removal and blade detachment occured. Vascular access was obtained utilizing retrograde approach. The target lesion was located in the forearm shunt. A peripheral cutting balloon" (pcb) was used to dilate the lesion. After an unspecified guidewire crossed the lesion, a 7fx3cm non-bsc introducer sheath was inserted to the lesion. Then the lesion was dilated with a 6. 00mmx2. 0cmx50cm peripheral cutting balloon" (pcb). The balloon was removed after dilation, however resistance was encountered. The sheath was removed after the balloon was removed from the patients body to perform homeostasis. However, a detached blade was noted at the distal tip of the sheath. No patient complications were reported and the patient's condition was good.

 
Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis. A visual and microscopic examination identified that an entire section of blade approximately 20mm in length was detached from the balloon. The pad where the blade detached was partially detached. The remaining blades were fully bonded to the balloon and no damage was noted to the other blades. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable cause of the reported difficulties may be due interaction with another device. (b)(4).

 
Event Description

It was reported that difficulty removal and blade detachment occured. Vascular access was obtained utilizing retrograde approach. The target lesion was located in the forearm shunt. A peripheral cutting balloon¿ (pcb) was used to dilate the lesion. After an unspecified guidewire crossed the lesion, a 7fx3cm non-bsc introducer sheath was inserted to the lesion. Then the lesion was dilated with a 6. 00mmx2. 0cmx50cm peripheral cutting balloon¿ (pcb). The balloon was removed after dilation, however resistance was encountered. The sheath was removed after the balloon was removed from the patient¿s body to perform homeostasis. However, a detached blade was noted at the distal tip of the sheath. 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
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key6092579
Report Number2134265-2016-09835
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/10/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/02/2018
Device MODEL NumberM001BP50620B0
Device Catalogue NumberBP506020B
Device LOT Number0019543681
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/24/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/23/2016
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: 11/10/2016 Patient Sequence Number: 1
Treatment
INTRODUCER SHEATH: 7F3CM MEDIKIT ULTRA HIGH FLOW
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