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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number 24628
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2018
Event Type  malfunction  
Event Description
It was reported that the blade lifted. The 90% stenosed target lesion was located in the moderately tortuous forearm shunt. A 6. 00mm/50cm 2cm peripheral cutting balloon was selected for use. During procedure, severe resistance was noted upon removing the device from the sheath after dilation. However, it was noted that the blade of the cutting balloon got lifted about 3mm on the proximal side. The procedure was completed with the device. No patient complications were reported.
 
Event Description
It was reported that the blade lifted. The 90% stenosed target lesion was located in the moderately tortuous forearm shunt. A 6. 00mm/50cm 2cm peripheral cutting balloon was selected for use. During procedure, severe resistance was noted upon removing the device from the sheath after dilation. However, it was noted that the blade of the cutting balloon got lifted about 3mm on the proximal side. The procedure was completed with the device. No patient complications were reported. The device was returned for analysis. A visual and microscopic examination was performed on the returned device. It was noted that a section of one of the blades approximately 6mm in length was partially detached from the proximal end of the balloon material. The remaining section of blade and measuring approximately 14mm in length and the entire blade pad remained undamaged and fully bonded to the balloon material. The entire 2cm of blade was accounted for. All other blades were intact and fully bonded to the balloon material. 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. The returned device was attached to an encore inflation unit. Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 11mm proximal of the distal markerband. An examination of the balloon material and markerband identified no issues which could potentially have contributed to this complaint. No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident. A visual and tactile examination identified that the shaft was kinked at the distal edge of the strain relief. No other issues were identified during the product analysis.
 
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Brand Name2CM PERIPHERAL CUTTING BALLOON
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key7793018
MDR Text Key117462476
Report Number2134265-2018-60218
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/19/2020
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0022017513
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/17/2018 Patient Sequence Number: 1
Treatment
GUIDEWIRE- KYOUSHA018; GUIDEWIRE- KYOUSHA018; INTRODUCER SHEATH- MOSQUITO SHEATH 6F3CM; INTRODUCER SHEATH- MOSQUITO SHEATH 6F3CM; GUIDEWIRE- KYOUSHA018; INTRODUCER SHEATH- MOSQUITO SHEATH 6F3CM
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