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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 24630
Device Problems Material Rupture (1546); Failure to Advance (2524); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2018
Event Type  malfunction  
Manufacturer Narrative
Patient identifier: (b)(6).Age at time of event: 18 years or older.
 
Event Description
It was reported that a balloon rupture occurred.The 40mmx10mm de novo concentrically shaped target lesion was located in the 80% stenosed non-calcified and non-tortuous left fistula.A 5.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, the physician used a 7f sheath for access and dilated the lesion with a non bsc balloon.However, the non bsc balloon kept recoiling.After that, the 2cm peripheral cutting balloon was used to dilate the lesion.There was some difficulty crossing the lesion.However, it was noted that the balloon burst at 2atm.The procedure was completed with another a 7.0mm/2.0cm/90cm peripheral cutting balloon and additional balloons.There were no patient complications reported and the patient was stable.
 
Event Description
It was reported that a balloon rupture occurred.The 40mmx10mm de novo concentrically shaped target lesion was located in the 80% stenosed non-calcified and non-tortuous left fistula.A 5.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, the physician used a 7f sheath for access and dilated the lesion with a non bsc balloon.However, the non bsc balloon kept recoiling.After that, the 2cm peripheral cutting balloon was used to dilate the lesion.There was some difficulty crossing the lesion.However, it was noted that the balloon burst at 2atm.The procedure was completed with another a 7.0mm/2.0cm/90cm peripheral cutting balloon and additional balloons.There were no patient complications reported and the patient was stable.
 
Manufacturer Narrative
Patient identifier: (b)(6).Age at time of event: 18 years or older.Updated device avail for evaluation, returned to manufacturer date, device eval by manufacturer, device return to manufacturer, evaluation method codes, evaluation result codes and evaluation conclusion codes.Device evaluated by mfr: the device was returned for analysis.The tip section of the device was visually and microscopically examined, and no issues were noted that could have potentially contributed to the complaint incident.A visual and microscopic examination identified no issues with the blades.All blades were present 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.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 7mm distal to the distal end of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination found no issues with the markerbands of the device.A visual and tactile examination identified no issues with the shaft of the device that could potentially have contributed to the complaint incident.No issues were identified during the product analysis.
 
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Brand Name
2CM PERIPHERAL CUTTING BALLOON
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8169696
MDR Text Key130527411
Report Number2134265-2018-64367
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,foreig
Type of Report Initial,Followup
Report Date 02/07/2019
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 Date04/25/2020
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0022043476
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2019
Initial Date Manufacturer Received 12/08/2018
Initial Date FDA Received12/17/2018
Supplement Dates Manufacturer Received01/17/2019
Supplement Dates FDA Received02/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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