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

Model Number	B1070-040
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was performed to treat a 80% stenosed and mildly tortuous lesion in the fistula artery.A 7.0x40mm armada 35 balloon dilatation catheter was advanced to the target lesion and the balloon inflated approximately 3 atmospheres over the rated burst pressure (rbp) and was noted to rupture.The bdc was removed however pieces of the balloon were noted to be separated and stuck along the sheath and guidewire.The separated pieces were removed using a snare device.The patient was noted to loss increased amount of blood and the procedure was completed with a non-abbott balloon.There were reported no adverse patient sequela.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.H6: medical device problem code 2017- above rbp.
Additional Manufacturer Narrative
The device was not returned for analysis.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.It was reported that the balloon was over inflated approximately 3 atmospheres over the rated balloon pressure and then the balloon ruptured.It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35/ armada 35ll global, ce, instructions 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 15 atmospheres as indicated on the product label.The patient was noted to have lost an increased amount of blood and the procedure was completed with a non-abbott balloon.The reported patient effect of hemorrhage/blood loss/bleeding is listed in the percutaneous transluminal angioplasty (pta) catheter, armada 35 / armada 35 ll, global, instructions for use (ifu) as a known patient effect.Based on the information received, the investigation determined that the reported balloon rupture appears to be related to user error/operational context; however, the separation and unexpected medical intervention appears to be related to circumstance of the procedure.A conclusive cause for the reported patient effect of hemorrhage/blood loss/bleeding and the relationship to the device, if any, cannot be determined.In this case, it is likely that the ifu violation and the combination of the 80% stenosed and mildly tortuous lesion resulted in the reported balloon rupture.Additionally, the ruptured balloon material likely did not allow the balloon to refold properly and subsequently resulted in the reported separation during removal.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: 20708005
• Report Number: 2024168-2024-13596
• Device Sequence Number: 8180948
• Product Code: LIT
• UDI-Device Identifier: 08717648154782
• UDI-Public: (01)08717648154782(17)271130(10)40625G1
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/06/2024

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 Model Number: B1070-040
• Device Catalogue Number: B1070-040
• Device Lot Number: 40625G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: UNKNOWN.; SHEATH: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown