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

Model Number	39347-100470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code (product code) - lit, dqy.
Event or Problem Description
It was reported that balloon rupture occurred.During the procedure, a 10 mm x 40 mm athletis balloon catheter was advanced for dilatation.However, before reaching the rated burst pressure, the balloon burst.There were no patient complications reported and there were no further information were reported.
Event or Problem Description
It was reported that balloon rupture occurred.During the procedure, a 10 mm x 40 mm athletis balloon catheter was advanced for dilatation.However, before reaching the rated burst pressure, the balloon burst.There were no patient complications reported and there were no further information were reported.
Additional Manufacturer Narrative
D2b: pro code (product code) - lit, dqy the following d4s were updated: d4: model number - 39347-100470, lot number - 30153169, catalog number - 39347-100470, expiration date - 09/14/2025, unique identifier (udi) # (b)(4).Device evaluated by mfr.: an athletis device 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 rated burst pressure for this device is 30 atmospheres.The returned device was attached to an encore inflation unit and positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 25mm distal from the proximal markerband.A visual and tactile examination identified no kinks or damage to the shaft and no damaged on the tip identified visually.

• 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: 17665232
• Report Number: 2124215-2023-44755
• Device Sequence Number: 6190539
• Product Code: LIT
• UDI-Device Identifier: 08714729974215
• UDI-Public: 08714729974215
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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: 09/14/2025
• Device Model Number: 39347-100470
• Device Catalogue Number: 39347-100470
• Device Lot Number: 0030153169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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