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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION GLADIATOR ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24686
Device Problem Material Rupture (1546)
Patient Problem Pain (1994)
Event Date 01/17/2020
Event Type  Injury  
Manufacturer Narrative
Initial reporter facility name : (b)(6) hospital.
 
Event Description
It was reported that balloon rupture and patient pain occurred.The severely stenosed target lesion was located in the mildly calcified radio-cephalic internal fistula.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced through a guidewire under a colored ultrasound.However, during the slow first inflation at 18 atmospheres, the patient cried out for pain.The colored ultrasound showed the balloon did not inflate, but when the balloon was withdrawn, it was confirmed that the balloon had burst.The device was removed without any intervention.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.
 
Manufacturer Narrative
E1: initial reporter facility name - (b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.A visual and microscopic examination identified a balloon longitudinal tear beginning approximately 8mm proximal of the proximal markerband and extending approximately 54mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the returned device.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No issues were identified during the product analysis.
 
Event Description
It was reported that balloon rupture and patient pain occurred.The severely stenosed target lesion was located in the mildly calcified radio-cephalic internal fistula.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced through a guidewire under a colored ultrasound.However, during the slow first inflation at 18 atmospheres, the patient cried out for pain.The colored ultrasound showed the balloon did not inflate, but when the balloon was withdrawn, it was confirmed that the balloon had burst.The device was removed without any intervention.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.
 
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Brand Name
GLADIATOR ELITE
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9752067
MDR Text Key180808972
Report Number2134265-2020-02099
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729809739
UDI-Public08714729809739
Combination Product (y/n)N
PMA/PMN Number
K132810
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/20/2022
Device Model Number24686
Device Catalogue Number24686
Device Lot Number0024298977
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2020
Initial Date Manufacturer Received 02/12/2020
Initial Date FDA Received02/25/2020
Supplement Dates Manufacturer Received03/27/2020
Supplement Dates FDA Received04/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age39 YR
Patient Weight55
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