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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 M001PCB8020900
Device Problems Cutter/Blade; Detachment Of Device Component
Event Date 07/07/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported that the a blade issue occurred. A 8. 00mm/2. 0cm/90cm 2cm peripheral cutting balloonas selected to treat the target lesion. During procedure inside patient, after one inflation one of the blades "came off" of the balloon. No patient complications were reported.

 
Manufacturer Narrative

Device evaluated by mfr. : a visual examination of the device revealed a 13 mm of one blade and blade pad had lifted from the balloon's proximal body; however, approximately 5 mm of blade pad was still attached. The blade was lifted toward a distal direction which would be consistent with the direction of device removal from the introducer sheath/patient. The remaining blades were fully bonded to the balloon and no damage was noted to the other blades. A visual and microscopic examination observed no damage to the tip. A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure. The returned device was attached to an encore inflation unit and the balloon was able to be inflated to its rated burst pressure of 10 atmospheres and maintained pressure with no leaks noted. The balloon inflated and deflated successfully. The encore inflation unit was verified before and after use using a calibrated pressure gauge. No kinks or damage were noticed along the shaft of the device. No other issues were identified during product analysis. 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 a blade issue occurred. A 8. 00mm/2. 0cm/90cm 2cm peripheral cutting balloonas selected to treat the target lesion. During procedure inside patient, after one inflation one of the blades "came off" of the balloon. No 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
linda leimer
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key5050980
Report Number2134265-2015-05799
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/05/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/25/2016
Device MODEL NumberM001PCB8020900
Device Catalogue NumberPCB802090
Device LOT Number0017228697
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/02/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/17/2014
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: 09/02/2015 Patient Sequence Number: 1
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