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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 H74939206120470
Device Problems Detachment Of Device Component; Tip
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 tip detachment occurred and fistula functionality was lost. A 12. 0 x40 75cm charger¿ balloon catheter was selected for use during a fistula angioplasty procedure in the patient's arm. Upon pulling the device back out of the sheath, the tip of the device broke off and was left inside of the patient's body. The reported complications were that the patient's "fistula was lost" which subsequently lead to the placement of a permacath. No further patient complications were reported.

 
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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 Key7287236
Report Number2134265-2018-01117
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939206120470
Device Catalogue Number3920612047
Device LOT Number0021277236
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 Received01/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/19/2017
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: 02/21/2018 Patient Sequence Number: 1
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