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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ATHLETIS PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION ATHLETIS PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 39347-051050
Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Stretched (1601); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2022
Event Type  Injury  
Event Description
It was reported that the balloon could not be deflated/difficult to remove.An athletis 5.0mm x 100mm x 50cm balloon dilatation catheter was selected for a dialysis shunt treatment in the forearm/upper arm using arteriovenous fistula thrombectomy procedure.The procedure was being performed to treat 100% stenosis, and the target lesion contained moderate tortuous severity.The lesion was dilated using the athletis, and the thrombus was removed.Negative pressure was then applied for one minute and the inflation lumen was flat, but balloon could not be deflated or removed from the sheath.When it was pulled forcibly with the guidewire being removed, the shaft got extended.The blood vessel was already opened during thrombectomy, so the balloon shaft was cut and the balloon tip was grasped using a tool.It was pulled to the opposite side of the sheath, and they were able to successfully remove stuck device.The procedure was able to be completed successfully using another athletis device without sequela.
 
Event Description
It was reported that the balloon could not be deflated/difficult to remove.An athletis 5.0mm x 100mm x 50cm balloon dilatation catheter was selected for a dialysis shunt treatment in the forearm/upper arm using arteriovenous fistula thrombectomy procedure.The procedure was being performed to treat 100% stenosis, and the target lesion contained moderate tortuous severity.The lesion was dilated using the athletis, and the thrombus was removed.Negative pressure was then applied for one minute and the inflation lumen was flat, but balloon could not be deflated or removed from the sheath.When it was pulled forcibly with the guidewire being removed, the shaft got extended.The blood vessel was already opened during thrombectomy, so the balloon shaft was cut and the balloon tip was grasped using a tool.It was pulled to the opposite side of the sheath, and they were able to successfully remove stuck device.The procedure was able to be completed successfully using another athletis device without sequela.It was also reported that there was an issue occurred that inflation pressure could not be increased even if it was applied during inflation.
 
Manufacturer Narrative
Correction to field b5: describe event or problem, h6: device codes.Device eval by manufacturer: returned product consisted of an athletis device from batch 29010667.Visual examination identified that the balloon was not folded, indicating that the device was subjected to positive pressure.A visual examination of the balloon material and marker bands identified no anomalies.Further examination identified the shaft was stretched and separated approximately 380mm distal of the strain relief, and damage was also noted at the tip.It was concluded that the inflation/deflation issue was unable to be confirmed due to the damage on the shaft inhibiting testing; however, the shaft/tip damage and separation are likely a result of using force when removing during the procedure.
 
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Brand Name
ATHLETIS PTA BALLOON DILATATION CATHETER
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14477769
MDR Text Key292476021
Report Number2134265-2022-05331
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729973720
UDI-Public08714729973720
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number39347-051050
Device Catalogue Number39347-051050
Device Lot Number0029010667
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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