MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; PERIPHERAL DILATATION CATHETER

Model Number	B1070-080
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat the av fistual with heavy calcification.The 7.0x80mm armada 35 balloon catheter could not hold pressure at 16 atmospheres and a rupture was noted.A new armada balloon was used to complete the procedure.There was no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection, functional testing and scanning electron microscopy (sem) analysis were performed on the returned device.The reported balloon rupture could not be confirmed; however, it is likely that the noted leak during return analysis is what the account perceived as the rupture since the balloon would not fully inflate or hold pressure.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.The balloon was ultimately sent to the sem lab for further analysis.The sem report determined leakage at the proximal seal may be attributed to exposure conditions and/or a materials/processing discrepancy at the proximal end of the seal.Cross-section views show a gap at the bond area of the seal.No significant mechanical damage associated with the failure mechanism was observed.The distal tip was documented, and no leakage was observed.It was reported that the balloon was overinflated to 16 atmospheres.It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35/ armada 35ll global, ce, instruction for use (ifu), states: ¿inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.¿ the rated burst pressure for this device is 14 atmospheres as indicated on the product label.In this case, it is not likely that the ifu violation contributed to the reported complaint given the balloon rupture could not be confirmed and a leak was noted.The investigation determined the noted leak at the proximal end of proximal balloon seal at shaft area appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: ARMADA
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 20237938
• Report Number: 2024168-2024-10956
• Device Sequence Number: 8667457
• Product Code: LIT
• UDI-Device Identifier: 08717648154805
• UDI-Public: (01)08717648154805(17)271031(10)40524G1
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2024

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 Model Number: B1070-080
• Device Catalogue Number: B1070-080
• Device Lot Number: 40524G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 77 KG