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	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pro code (product code) - dqy.
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 twice to 25atm for 20 seconds each.On the second inflation the balloon 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.
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 twice to 25atm for 20 seconds each.On the second inflation the balloon 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.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned and analysis was completed.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.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located at the distal markerband.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to be kinked at more than one location.Both markerbands were undamaged and present on the shaft of 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: 12950606
• Report Number: 2134265-2021-15019
• Device Sequence Number: 17384411
• Product Code: LIT
• 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): 01/12/2022

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: 04/26/2022
• Device Model Number: 39347-080450
• Device Catalogue Number: 39347-080450
• Device Lot Number: 0026261535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• 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