MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ATHLETIS PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	39347-081070
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon would not deflate.An athletis 8.0mm x 100mm x 75cm pta balloon dilation catheter was selected for use in an arteriovenous (av) fistulagram procedure for treatment of the 75% venous stenosis.The balloon was moved to the stenosis and inflated, the balloon immediately had high atmospheric pressure instead of a gradual increase.The balloon fully inflated for 30 seconds, but would not deflate.The balloon deflated enough to remove it from the sheath after multiple inflation and deflation attempts were made.There were no patient complications.Patient was stable the entire procedure.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Pro code (product code): dqy.
Event or Problem Description
It was reported that the balloon would not deflate.An athletis 8.0mm x 100mm x 75cm pta balloon dilation catheter was selected for use in an arteriovenous (av) fistulagram procedure for treatment of the 75% venous stenosis.The balloon was moved to the stenosis and inflated, the balloon immediately had high atmospheric pressure instead of a gradual increase.The balloon fully inflated for 30 seconds, but would not deflate.The balloon deflated enough to remove it from the sheath after multiple inflation and deflation attempts were made.There were no patient complications.Patient was stable the entire procedure.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.D2b: pro code (product code) - dqy.Device evaluated by mfr: an athletis 8.0mm x 100mm x 75cm, batch number 27212384, 31atm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was attached to an inflation unit and the balloon was inflated to its rated burst pressure of 31 atmospheres using inflation media glycerol/water and no leaks were noted.A vacuum was then applied, and the balloon was unable to deflate fully due to multiple shaft kinks.The inflation device was verified at 31 atmospheres before and after use with a calibrated pressure gauge.A visual examination identified no issues with the markerbands or the tip of the device that could have contributed to the complaint incident.A visual and tactile examination found multiple shaft kinks along the length of the device.This type of damage is consistent with excessive force being applied to the device.

• Brand Name: ATHLETIS PTA BALLOON DILATATION CATHETER
• Common Device Name: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13239887
• Report Number: 2134265-2021-16522
• Device Sequence Number: 11823142
• Product Code: LIT
• UDI-Device Identifier: 08714729974116
• UDI-Public: 08714729974116
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2024
• Device Model Number: 39347-081070
• Device Catalogue Number: 39347-081070
• Device Lot Number: 0027212384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown