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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 H74939206070810
Device Problems Shaft (955); Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/12/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: a charger balloon was received for analysis. A visual examination confirmed that the balloon had been subjected to positive pressure. The 5fr introducer sheath used during the procedure was not returned for analysis. The device was received in two separate sections. The proximal section consisted of shaft and hub/manifold and the distal section consisted of proximal balloon bond, balloon and tip. A visual and tactile examination identified severe stretching and kinking damage along the length of the shaft. A complete break was also identified at the proximal balloon bond. This type of damage is consistent with excessive force being applied to the delivery system. A visual and microscopic examination of the proximal balloon bond and catheter identified no issues that could have contributed to the complaint incident. The balloon was unfolded and had been subjected to positive pressure. Blood was noted within the balloon which is evidence of a device leak. A visual examination identified a small circumferential tear in the balloon material approximately 3mm distal to the distal edge of the distal markerband. The circumferential tear was approximately 5mmm in length. A microscopic examination on the balloon identified no issues that could have contributed to the complaint incident. A visual and microscopic examination identified no damage or any issues with the markerbands or tip of the device. No other issues were identified during the product analysis. There is no evidence that the device failed to meet specification. 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 shaft break occurred. The target lesion was located in the posterior tibial artery. After a 5fr sheath was introduced, a 7. 0 x80 135cm charger¿ balloon catheter was advanced for dilatation and was able to complete the angioplasty. However, upon removal of the device, the balloon shaft separated in half. The distal portion of the shaft was stuck inside the sheath and was removed together with the sheath. The rest of the shaft was also completely removed and the procedure was completed with a different device. 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 Key6928795
MDR Text Key89947588
Report Number2134265-2017-09694
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 09/13/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/09/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/16/2020
Device MODEL NumberH74939206070810
Device Catalogue Number3920607081
Device LOT Number0020654904
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/19/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/19/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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