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

Model Number	39347-051050
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Stretched (1601); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon could not be deflated/difficult to remove.An athletis 5.0mm x 100mm x 50cm balloon dilatation catheter was selected for a dialysis shunt treatment in the forearm/upper arm using arteriovenous fistula thrombectomy procedure.The procedure was being performed to treat 100% stenosis, and the target lesion contained moderate tortuous severity.The lesion was dilated using the athletis, and the thrombus was removed.Negative pressure was then applied for one minute and the inflation lumen was flat, but balloon could not be deflated or removed from the sheath.When it was pulled forcibly with the guidewire being removed, the shaft got extended.The blood vessel was already opened during thrombectomy, so the balloon shaft was cut and the balloon tip was grasped using a tool.It was pulled to the opposite side of the sheath, and they were able to successfully remove stuck device.The procedure was able to be completed successfully using another athletis device without sequela.
Event or Problem Description
It was reported that the balloon could not be deflated/difficult to remove.An athletis 5.0mm x 100mm x 50cm balloon dilatation catheter was selected for a dialysis shunt treatment in the forearm/upper arm using arteriovenous fistula thrombectomy procedure.The procedure was being performed to treat 100% stenosis, and the target lesion contained moderate tortuous severity.The lesion was dilated using the athletis, and the thrombus was removed.Negative pressure was then applied for one minute and the inflation lumen was flat, but balloon could not be deflated or removed from the sheath.When it was pulled forcibly with the guidewire being removed, the shaft got extended.The blood vessel was already opened during thrombectomy, so the balloon shaft was cut and the balloon tip was grasped using a tool.It was pulled to the opposite side of the sheath, and they were able to successfully remove stuck device.The procedure was able to be completed successfully using another athletis device without sequela.It was also reported that there was an issue occurred that inflation pressure could not be increased even if it was applied during inflation.
Additional Manufacturer Narrative
Correction to field b5: describe event or problem, h6: device codes.Device eval by manufacturer: returned product consisted of an athletis device from batch 29010667.Visual examination identified that the balloon was not folded, indicating that the device was subjected to positive pressure.A visual examination of the balloon material and marker bands identified no anomalies.Further examination identified the shaft was stretched and separated approximately 380mm distal of the strain relief, and damage was also noted at the tip.It was concluded that the inflation/deflation issue was unable to be confirmed due to the damage on the shaft inhibiting testing; however, the shaft/tip damage and separation are likely a result of using force when removing during the procedure.

• 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: 14477769
• Report Number: 2134265-2022-05331
• Device Sequence Number: 5321280
• Product Code: LIT
• UDI-Device Identifier: 08714729973720
• UDI-Public: 08714729973720
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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: 03/08/2025
• Device Model Number: 39347-051050
• Device Catalogue Number: 39347-051050
• Device Lot Number: 0029010667
• 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: 05/03/2022
• Supplement Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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