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

Model Number	B2050-100
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Codes	Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified vessel in the left external iliac artery.The 5.0x100mm armada 35 balloon catheter was prepared and had slight resistance with the anatomy but was advanced to the lesion.However, at first inflation with a pressure of 8 atmospheres (atms) the balloon became stuck with the calcification and ruptured.The balloon was fully deflated upon removal.Resistance was noted upon withdrawal and more force applied to remove the balloon catheter.The balloon separated on the guide wire but the separated pieces and the guide wire were all removed as a single unit.During removal, the atriotomy ripped and cutdown was performed to patch it.Nothing was left in the patient's anatomy.Another device was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.It was reported that resistance was felt with the challenging anatomy during removal of the bdc and additional force was applied to successfully remove the bdc.It should be noted that the percutaneous transluminal angioplasty (pta), armada 35/ armada 35 ll, global instructions for use (ifu), states: do not advance the armada 35 / armada 35 ll pta catheter against significant resistance.The cause of resistance should be determined via fluoroscopy and remedial action taken.In this case, it is likely that the ifu violation and the challenging anatomy contributed to the reported balloon separation.The investigation determined the reported balloon rupture, difficulty advancing and removing the device, unspecified tissue injury and surgical intervention appear to be related to circumstances of the procedure.The reported separation appears to be related to user error/circumstance of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.H6: medical device problem code 4582 removed.

• 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: 14824127
• Report Number: 2024168-2022-06858
• Device Sequence Number: 4961245
• Product Code: LIT
• UDI-Device Identifier: 08717648155208
• UDI-Public: 08717648155208
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 07/18/2022

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: 07/31/2025
• Device Model Number: B2050-100
• Device Catalogue Number: B2050-100
• Device Lot Number: 20207G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 06/26/2022
• Supplement Report FDA Received Date: 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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: 6FR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 99 KG