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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 H74939206081010
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation of Vessels (2135); Diminished Pulse Pressure (2606)
Event Date 02/17/2017
Event Type  Injury  
Manufacturer Narrative

Device evaluated by mfr. : it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported that a vessel perforation occurred. The target lesion was located in the left iliac artery. An 8x100 innova stent was implanted in the vessel. Post-dilation of the stent was performed with an 8. 0x100, 135cm charger¿ balloon catheter and "it looked great. " it was then decided to dilate the lesion proximal to the stent where there was some plaque and a vessel perforation occurred. The patient's pressures started to drop, however the balloon was reinflated and the patient's status improved. A 7x50 non-bsc stent was then advanced to cover the perforation. Post-dilation was performed and the perforation was completely covered. The patient's pressures immediately started to rise. The patient was kept for observation and was doing "really well. " the following day the patient was considered completely recovered and was discharged.

 
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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 Key6393748
MDR Text Key69555801
Report Number2134265-2017-01897
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 02/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/09/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberH74939206081010
Device Catalogue Number3920608101
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 Received02/17/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/09/2017 Patient Sequence Number: 1
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