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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY MAXFORCE TTS?; DILATOR, ESOPHAGEAL
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BOSTON SCIENTIFIC - GALWAY MAXFORCE TTS?; DILATOR, ESOPHAGEAL Back to Search Results
Model Number M00589120
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a maxforce tts balloon dilatation catheter was used during an upper endoscopy in the esophagus.According to the complainant, when removing the device from the packaging, it was observed that the distal tip of the balloon was bent.It was confirmed that there was no damaged noted to the packaging.The procedure was completed with another maxforce tts balloon dilatation catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
 
Manufacturer Narrative
Reported event of distal tip bent.Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Manufacturer Narrative
A visual examination revealed a kink in the tip section of the device.The kink was located at 1cm proximal to the tip.No other damage was visible along the entire length of the device.No issues were noted with the balloon.The device history record review confirms that this device met all material, assembly and performance specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.A review of the device labeling and directions for use (dfu) found the device was used according to its label.The reported event of distal tip bent was confirmed.The most probable root cause of this event is handling damage.The complaint was likely caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping, at the end of a procedure; or when packaging for return.
 
Event Description
It was reported to boston scientific corporation that a maxforce tts balloon dilatation catheter was used during an upper endoscopy in the esophagus.According to the complainant, when removing the device from the packaging, it was observed that the distal tip of the balloon was bent.It was confirmed that there was no damaged noted to the packaging.The procedure was completed with another maxforce tts balloon dilatation catheter.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
 
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Brand Name
MAXFORCE TTS?
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
ingrid matte
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key3631943
MDR Text Key17388466
Report Number3005099803-2014-01066
Device Sequence Number1
Product Code KNQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K934697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 01/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/18/2014
Device Model NumberM00589120
Device Catalogue Number8912
Device Lot Number0015618361
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/28/2014
Initial Date FDA Received02/18/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/14/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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