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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 Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/23/2020
Event Type  Injury  
Manufacturer Narrative
Age at time of event: 70's.
 
Event Description
It was reported that one of the blade was missing and could not be found.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified cephalic vein.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, the dilation was performed six times on the forearm at 10atm.Upon removal, mild and unusual resistance on the sheath part was felt.The balloon was pulled out as it was, however one out of the four blades was noted missing when checked.Ct imaging was performed from the sheath puncture part to the area around the shunt to the central vein up to the pulmonary artery, but it could not be found.The procedure was completed using this device.No further complications reported and patient was fine.
 
Manufacturer Narrative
A2.Age at time of event- 70's.Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination was performed on the returned device.It was noted that one of the blades was completely detached from the balloon material.The entire blade pad remained bonded to the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.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.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 1mm proximal of the distal markerband.An examination of the balloon material and markerbands 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 found no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that one of the blade was missing and could not be found.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified cephalic vein.A 6.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During the procedure, the dilation was performed six times on the forearm at 10atm.Upon removal, mild and unusual resistance on the sheath part was felt.The balloon was pulled out as it was, however one out of the four blades was noted missing when checked.Ct imaging was performed from the sheath puncture part to the area around the shunt to the central vein up to the pulmonary artery, but it could not be found.The procedure was completed using this device.No further complications reported and patient was fine.
 
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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 Key10683698
MDR Text Key211471445
Report Number2134265-2020-14171
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/20/2022
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0025739587
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Date Manufacturer Received10/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE- FUGA; GUIDEWIRE- FUGA; INFLATION DEVICE- NIPRO; INFLATION DEVICE- NIPRO; INTRODUCER SHEATH- VAIVT ACE 7F 3CM; INTRODUCER SHEATH- VAIVT ACE 7F 3CM; GUIDEWIRE- FUGA; INFLATION DEVICE- NIPRO; INTRODUCER SHEATH- VAIVT ACE 7F 3CM
Patient Outcome(s) Other;
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