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

Model Number	B1120-060
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event estimated as (b)(6) 2024.D4: the udi is not known as the part and lot number were not provided.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 an unspecified armada balloon basted (ruptured) and when pulled the balloon separated.The separated portion was noted to be missing in the patient.There was no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.A review of production records and the complaint handling database was not performed because the part/lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported difficulties.Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.Balloon material ruptures can be affected by numerous factors including, but not limited to, balloon damage during processing of the balloon material, materials, inflation technique, and interactions with other devices or lesion calcification.Additionally, material separation can be affected by numerous factors including, but not limited to, manipulation against resistance, material properties, technique, and interactions with other devices or lesion calcification.In this case, a conclusive cause for the reported complaint could not be determined since the device was not returned for analysis and limited information was reported.There is no indication of a product quality issue with respect to manufacture, design, or labeling.B2 correction: outcomes attributed to ae updated from other serious to required intervention.B3 correction: date of event updated from (b)(6) 2024.D4 correction: model # updated from n/a to unk.D9 correction: device available for evaluation updated from asku to not returning.E1 correction: initial reporter updated from non-health professional to physician: dr.(b)(6).H6 correction: code 2687, 4614 were removed and codes 2199 and 4582 were added.
Event or Problem Description
Subsequently, after the initial report was filed it was noted that the armada balloon ruptured at 8 atmospheres.The entirety of the balloon did come out and the metal distal marker separated from the balloon.The separated marker remained on the wire and was removed from the patient.Another device was used to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.The reported material rupture could not be tested due to the device condition.A review of the production records and the corrective and preventive actions (capa) database was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported difficulties.It was reported that the balloon rupture and separated during the procedure.Analysis of the device confirmed the material separation.The balloon was not returned; therefore, the balloon rupture could not be confirmed.Analysis also noted bunching and tears on the inner and outer member.This type of damage is consistent with manipulation against resistance.In this case, it is possible that the device interacted with the patient¿s anatomy or an accessory device during the procedure, resulting in the noted tears and bunching.Tears and bunching could impact the integrity of the material, possibly contributing to the reported material separation and rupture; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D4 correction: model, catalog number updated from unk armada to b1120-060.D4 correction: lot number updated from unknown to 11112g1.D9 correction: device available for evaluation updated from no to yes.H6 correction: type of investigation code 4114 removed.H6: correction investigation findings code 3221 removed.
Event or Problem Description
Subsequently, after the initial report was filed it was reported that the procedure as to treat a subclavian artery.No additional information was provided.

• 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: 19321484
• Report Number: 2024168-2024-05886
• Device Sequence Number: 15037626
• Product Code: LIT
• UDI-Device Identifier: 08717648154997
• UDI-Public: (01)08717648154997(17)250430(10)11112G1
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2025

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: 04/30/2025
• Device Model Number: B1120-060
• Device Catalogue Number: B1120-060
• Device Lot Number: 11112G1
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 01/06/2025
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 11/27/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White