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

Model Number	39347-080470
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon failed to deflate.The patient presented with slow flow and underwent arteriovenous fistulagram.An 8.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was used.However, during the procedure, the balloon would not deflate.The physician tried using two different non-boston scientific syringes and ended up using a 21g needle to pop the balloon.The physician pierced the balloon through the skin and was able to pull it through the sheath.The procedure was completed, and no patient complications were reported.
Additional Manufacturer Narrative
B5: describe event or problem: additional information.
Event or Problem Description
It was reported that the balloon failed to deflate.The patient presented with slow flow and underwent arteriovenous fistulagram.An 8.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was used.However, during the procedure, the balloon would not deflate.The physician tried using two different non-boston scientific syringes and ended up using a 21g needle to pop the balloon.The physician pierced the balloon through the skin and was able to pull it through the sheath.The procedure was completed, and no patient complications were reported.It was further reported that the 80% stenosed target lesion was located in an arteriovenous fistula in the non-tortuous and non-calcified left upper arm.The balloon was inflated less than 20 seconds.The patient did not experience any symptoms while the balloon remained inflated.
Additional Manufacturer Narrative
Device evaluated by mfr.: athletis 8.0mm x 40mm x 75cm was received for analysis.The device was returned attached to the customer's syringe.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The investigator successfully applied full negative pressure to the device using the customers syringe which indicates that there is no blockage/obstruction within the device /inflation lumen.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 28mm proximal of the tip.The balloon could not be fully deflated due to the balloon rupture.As per athletis specification the rated burst pressure for this device is 40 atmospheres.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that the balloon failed to deflate.The patient presented with slow flow and underwent arteriovenous fistulagram.An 8.0mm x 40mm x 75cm athletis pta balloon dilatation catheter was used.However, during the procedure, the balloon would not deflate.The physician tried using two different non-boston scientific syringes and ended up using a 21g needle to pop the balloon.The physician pierced the balloon through the skin and was able to pull it through the sheath.The procedure was completed, and no patient complications were reported.It was further reported that the 80% stenosed target lesion was located in an arteriovenous fistula in the non-tortuous and non-calcified left upper arm.The balloon was inflated less than 20 seconds.The patient did not experience any symptoms while the balloon remained inflated.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16026865
• Report Number: 2124215-2022-52859
• Device Sequence Number: 17940306
• Product Code: LIT
• UDI-Device Identifier: 08714729974055
• UDI-Public: 08714729974055
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2025
• Device Model Number: 39347-080470
• Device Catalogue Number: 39347-080470
• Device Lot Number: 0029579520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 12/16/2022; 01/10/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 01/04/2023; 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown