MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B1080-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
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 iliac artery with moderate calcification and moderate tortuosity.The 8x40 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was used and after deflating the balloon, it was attempted to pull out the balloon from the sheath but there was resistance and the balloon ripped.Angiography was performed but the piece of balloon was not seen.There was no adverse patient sequela and blood flow is proper in all vessels; however, there is the potential the material remains in the patient.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported ripped off and noted separated balloon was confirmed.The reported difficulty removing the device could not be replicated in a testing environment due to the condition of the returned device.Production record and corrective and preventive 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 no other similar complaints from this lot.The reported patient effect of embolism is listed in the percutaneous transluminal angioplasty (pta) catheter, armada 35 / armada 35 ll, global, instruction for use, as a known patient effect.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device; however, the reported ripped off and noted balloon separation, hospitalization and surgical intervention appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effect of embolism and the relationship to the device, if any, cannot be determined.Possible factors that can contribute to difficult to remove/resistance with the introducer sheath post-inflation include, but are not limited to, loose balloon folds, guiding catheter lumen obstructions, kinks, bends, procedural technique, insufficient support or interactions with other devices.In this case, a conclusive cause for the reported difficulty could not be determined.Additionally, it was reported that as difficulty removing the device was experienced, the balloon ripped off.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: health effect - clinical code 2687 removed; 4438 added.H6: health effect - impact codes 4607 and 4624 added.
Event or Problem Description
It was reported that the procedure was to treat the iliac artery with moderate calcification and moderate tortuosity.The 8x40 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was used and after deflating the balloon, it was attempted to pull out the balloon from the sheath but there was resistance and the balloon ripped.Angiography was performed but the piece of balloon was not seen.There was no adverse patient sequela and blood flow is proper in all vessels; however, there is the potential the material remains in the patient.Subsequent to the initially filed report additional information was received which indicated that the balloon was inflated once to 7 atmospheres and negative pressure was held continuously during removal.The balloon was fully deflated upon removal and the device was removed with a sheath as the device could not be pulled through the sheath.The patient was re-admitted to the hospital due to vascular occlusion distal to the dilation site.On march 11, the patient had angiography as they were still having symptoms.On march 25, surgery was performed and the remains of the balloon were removed from the external iliac artery.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 18856935
• Report Number: 2024168-2024-02883
• Device Sequence Number: 20903531
• Product Code: LIT
• UDI-Device Identifier: 08717648154867
• UDI-Public: (01)08717648154867(17)260731(10)30213G1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/12/2024

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: 07/31/2026
• Device Catalogue Number: B1080-040
• Device Lot Number: 30213G1
• 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: 02/20/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DESTINATION 6F.
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Unknown