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

Model Number	39347-080450
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the balloon ruptured.An 8.0mm x 40mm x 50cm athletis balloon catheter was used to treat a previously placed wallstent in the cephalic vein that was 75% stenosed, moderately tortuous, and mildly calcified.The athletis balloon was advanced to the target lesion, inflated to 12atm and then ruptured.The damage was noted to be the shape of a pinhole.The procedure was completed with another athletis balloon.The patient was reported in good condition.
Additional Manufacturer Narrative
Device evaluated by manufacturer: 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 31 atmospheres as per 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 5mm distal from the distal markerband.A visual and tactile examination identified no kinks or damage to the shaft or tip which may have potentially contributed to the complaint incident.
Event or Problem Description
It was reported the balloon ruptured.An 8.0mm x 40mm x 50cm athletis balloon catheter was used to treat a previously placed wallstent in the cephalic vein that was 75% stenosed, moderately tortuous, and mildly calcified.The athletis balloon was advanced to the target lesion, inflated to 12atm, ruptured, and was noted to be the shape of a pinhole.The procedure was completed with another athletis balloon.The patient was reported in good condition.

• 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: 12900796
• Report Number: 2134265-2021-14951
• Device Sequence Number: 3900057
• Product Code: DQY
• UDI-Device Identifier: 08714729974048
• UDI-Public: 08714729974048
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021
• 2 Devices were Involved in the Event: 1 2

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: 04/27/2024
• Device Model Number: 39347-080450
• Device Catalogue Number: 39347-080450
• Device Lot Number: 0027223744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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