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

Model Number	39347-051070
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b pro code (product code): lit, dqy.Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.The returned device was attached to an inflation unit and positive pressure was applied; the balloon was inflated to its rate of burst pressure atmospheres for using deionized water.A vacuum was then applied, and the balloon was fully deflated in less than 30 second.The inflation device was verified at 40 atmospheres, before and after use with calibrated pressure gauge.His inflation to rated burst pressure and deflation was repeated three times with full balloon deflation of the balloon being achieved in less than 30 seconds on every occasion.No issues were identified with balloon inflation or deflation.No issues were noted with the tip of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found that the shaft was free from kinks or damage.
Event or Problem Description
It was reported that deflation issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified brachial vein.A 5.0mm x 100mm x 75cm athletis balloon catheter was advanced for dilation.During the procedure, the balloon was first inflated at 30 atmospheres for 30 seconds.However, upon deflating the balloon, it could not decompress.The negative pressure was kept applied and was achieved in about 1 minute instead of 15 seconds.The balloon was removed in a deflated state, and the procedure was completed with a 6.0mm x 100mm x 75cm athletis balloon.No complications were reported.

• Brand Name: ATHLETIS PTA BALLOON DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18618917
• Report Number: 2124215-2024-02312
• Device Sequence Number: 2465723
• Product Code: LIT
• UDI-Device Identifier: 08714729973737
• UDI-Public: 08714729973737
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/31/2024

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: 06/26/2026
• Device Model Number: 39347-051070
• Device Catalogue Number: 39347-051070
• Device Lot Number: 0031904943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown