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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 M001BP90620B0
Device Problems Cutter; Detachment of Device or device Component
Event Date 08/10/2017
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that blade detachment occurred. A 90% stenosed target lesion was located in the moderately tortuous and moderately calcified poplitieal artery. A 6mm x 2cm peripheral cutting balloon¿ was selected for use. During procedure, the balloon was inflated for 30 seconds for 3 inflations at 7atm. When this device was withdrawn from the patient's body, a slight resistance was felt when the balloon was removed from the sheath. Upon checking the device after removal, it was noted that one of the blades became detach. However, angiography could not confirm the whereabouts of the detached blade inside the patient's body. The procedure was completed using this device. No further patient complications were reported.

 
Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis. The 6fr sheath used during the procedure was not returned for analysis. A visual and microscopic examination of the 2cm pcb device identified that one of the blades and a section of one of the pads was completely detached from the balloon material. The detached section of pad and 2cm of detached blade were not returned for analysis. All other blades were present and fully bonded to the balloon material. No issues were noted with the blades or pads. A visual and tactile examination found no kinks or damage along the shaft of the device. No other issues were identified during the product analysis. The balloon was unfolded which indicates it has been subjected to positive pressure. A visual and microscopic examination identified no damage or any issues with the balloon material that could have contributed to the complaint incident. No other issues were identified during the product analysis. A electronic device history record review relating to device batch was performed and there is no evidence that the device failed to meet specification prior to shipping. 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 blade detachment occurred. A 90% stenosed target lesion was located in the moderately tortuous and moderately calcified poplitieal artery. A 6mm x 2cm peripheral cutting balloon was selected for use. During procedure, the balloon was inflated for 30 seconds for 3 inflations at 7atm. When this device was withdrawn from the patient's body, a slight resistance was felt when the balloon was removed from the sheath. Upon checking the device after removal, it was noted that one of the blades became detach. However, angiography could not confirm the whereabouts of the detached blade inside the patient's body. The procedure was completed using this device. No further patient complications were reported.

 
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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 Key6825453
Report Number2134265-2017-08570
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 08/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/23/2019
Device MODEL NumberM001BP90620B0
Device Catalogue NumberBP906020B
Device LOT Number20324349
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/16/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/16/2017
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: 08/28/2017 Patient Sequence Number: 1
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