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

Model Number	B1050-080
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery.The 5x80mm armada 35 balloon dilatation catheter (bdc) was advance to the target lesion; however, the balloon failed to inflate after several attempts.The bdc was removed from the patient.Outside of the patient another attempt was made to inflate the balloon and pressure was applied to 24 atmospheres (atm); however, the balloon still did not inflate.Another armada balloon was used to complete the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.Return device analysis found there was a leak noted at 6atm at the proximal end of hub at guide wire port.Bubbles were noted in the guide wire port when indeflator was pressurized.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was returned.Visual inspection, functional testing, scanning electron microscopy (sem) and chem analysis were performed on the returned device.The reported inflation issue was confirmed, and a leak was noted on the retuned device.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the reported information and the observations from the returned analysis, a definitive cause for the reported inflation issue and noted leak could not be determined.There was no leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.According to sem analysis no leakage or blockages were observed at the distal end of the luer.Sem reported that contamination was observed in the balloon between the proximal marker and proximal balloon seal.Fourier transform infrared spectrometer (ftir) testing was performed to identify the noted contamination found and it was concluded the contamination could be blood plasma/serum, that could be the obstruction at some point of the inflation path.In this case, it is possible that the noted contamination contributed to the reported inflation issue; however, a conclusive cause cannot be determined.Additionally, sem report said the device leakage from the proximal end of the luer may possibly be attributed to gaps/channels in the adhesive bonding area, but it was reported by the account that the device was subjected to a higher pressure that recommended outside of the patient to see if the balloon inflates, this handling could affect the adhesive bonding.It may be possible that the adhesive bonding was compromised during the multiple inflation attempts and/or higher-pressure inflation and subsequently resulting in the noted leak during return analysis; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 19996182
• Report Number: 2024168-2024-09658
• Device Sequence Number: 8585580
• Product Code: LIT
• UDI-Device Identifier: 08717648154621
• UDI-Public: (01)08717648154621(17)240731(10)10226G1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 11/26/2024

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 Expiration Date: 07/31/2024
• Device Model Number: B1050-080
• Device Catalogue Number: B1050-080
• Device Lot Number: 10226G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2021
• 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
• Patient Sex: Unknown