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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 Material Rupture (1546); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address: (b)(6).
 
Event Description
It was reported that the balloon ruptured and the blade lifted from the balloon.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified arteriovenous fistula.A 6.00mmx2.0cmx50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 6 atmospheres for 10 seconds.After the catheter was pulled out, the blade was found torn.The middle part of the blade was torn and the ends of the blade were attached to both ends of the balloon.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
E1 - initial reporter address: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.A pcb 6.0/20/50 was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.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 10mm distal of the proximal markerband.An examination of the markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination was performed on the returned device.It was noted that approximately 5mm of the proximal end of one of the blades was lifted from the balloon pad and 8mm approximately of the distal end of one of the blades was lifted.The remaining 15mm and 11mm of the blades and blade pads 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.The customers sheath was returned with the device and damage was noted at the tip of the sheath.A visual and microscopic examination observed no damage to the tip.A visual and tactile examination identified no kinks or damage to the shaft of the device.This concludes the product analysis.
 
Event Description
It was reported that the balloon ruptured and the blade lifted from the balloon.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified arteriovenous fistula.A 6.00mmx2.0cmx50cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 6 atmospheres for 10 seconds.After the catheter was pulled out, the blade was found torn.The middle part of the blade was torn and the ends of the blade were attached to both ends of the balloon.The procedure was completed with another of the same device.No patient complications were reported.
 
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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 Key12523895
MDR Text Key273108731
Report Number2134265-2021-11986
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 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/24/2023
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0027367685
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2021
Date Manufacturer Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
INTRODUCER SHEATH - MOSQUITO SHEATH 6FR 3CM; INTRODUCER SHEATH - MOSQUITO SHEATH 6FR 3CM; INTRODUCER SHEATH - MOSQUITO SHEATH 6FR 3CM
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