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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CHARGER¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC - GALWAY CHARGER¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939206070470
Device Problems Balloon (419); Detachment Of Device Component (1104); Material Rupture (1546); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/05/2017
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 balloon rupture and tip detachment occurred. The 50-65% stenosed target lesion was located in the non tortuous and moderately calcified superficial femoral artery (sfa). After implanting a 8x40mm non-bsc stent, a 7. 0 x40, 75cm charger¿ balloon catheter was advanced for post dilatation; however, upon the first inflation at 20 atmospheres, the balloon ruptured and the tip of the catheter broke. Snaring was done and the procedure was completed. No patient complications were reported and the patient's status was fine.

 
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Brand NameCHARGER¿
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key6590539
MDR Text Key75959516
Report Number2134265-2017-05088
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK112697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 05/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/21/2020
Device MODEL NumberH74939206070470
Device Catalogue Number3920607047
Device LOT Number0020314061
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/22/2017
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: 05/25/2017 Patient Sequence Number: 1
Treatment
STENT: 8X40MM EVERFLEX
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