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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY XXL¿ ESOPHAGEAL DILATOR, ESOPHAGEAL

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BOSTON SCIENTIFIC - GALWAY XXL¿ ESOPHAGEAL DILATOR, ESOPHAGEAL Back to Search Results
Model Number M001145520
Device Problems Shaft; Material Perforation; Device Damaged Prior to Use ; Device Damaged by Another Device
Event Date 08/23/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that shaft perforation occurred. A 16-4/5. 8/75 xxl esophageal balloon catheter was selected to dilate the target lesion. However during tracking of a non-bsc guide wire, the guide wire poked out of the side of the balloon catheter right after the hub. The device was not used and the procedure was completed with another of the same device. Patient's status was good.

 
Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis. The returned device was attached to an encore inflation unit and inflated to its rated burst pressure with no leaks or drop in pressure noted. The inflation device was verified at its rated burst pressure before and after use with a calibrated pressure gauge. The balloon deflated within the allocated 60 seconds when negative pressure was applied. The deflation time was recorded using the digital timer. A visual and tactile examination identified two kinks at the base of the hub. However, no perforation was evident. This type of damage is consistent with excessive force being applied to the delivery system when being handled. A 0. 035inch guide wire was successfully inserted with slight resistance encountered at the base of the hub where the device had been kinked. No other issues were identified during the 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 shaft perforation occurred. A 16-4/5. 8/75 xxl¿ esophageal balloon catheter was selected to dilate the target lesion. However during tracking of a non-bsc guide wire, the guide wire poked out of the side of the balloon catheter right after the hub. The device was not used and the procedure was completed with another of the same device. Patient's status was good.

 
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Brand NameXXL¿ ESOPHAGEAL
Type of DeviceDILATOR, ESOPHAGEAL
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 Key5959657
Report Number2134265-2016-08244
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/24/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/10/2019
Device MODEL NumberM001145520
Device Catalogue Number14-552
Device LOT Number0019240212
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/31/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/24/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/13/2016
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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