MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	1013470-200
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was received.Investigation is not yet completed.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during device preparation, the armada 18 balloon catheter was wiped down but the balloon was not soaked as instructed in the ifu.After the device was advanced to the unspecified lesion, the armada 18 balloon ruptured at 10 atmospheres during the second inflation.There were no reported adverse patient effects and no clinically significant delay in the procedure.Another armada balloon was used to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned balloon catheter, and the reported balloon rupture was confirmed.Additionally, scratches at the pinhole rupture site were noted.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 incidents and/or complaints reported from this lot.It should be noted that the pta, catheter, armada 18, electronic instructions for use (eifu) states: flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution via the guide wire access port prior to use.Consider the use of systemic heparinization.In this case, the reported ifu deviation/incorrect prep did not cause or contribute to the reported rupture.The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure.The noted scratches at the pinhole rupture site suggest interaction causing damage to the outer surface of the balloon material.In this case, it is likely that during the second inflation, the balloon became compromised against the anatomy resulting in the reported balloon rupture at 10 atmospheres.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11673661
• Report Number: 2024168-2021-03174
• Device Sequence Number: 11851358
• Product Code: LIT
• UDI-Device Identifier: 08717648208461
• UDI-Public: 08717648208461
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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: 02/29/2024
• Device Model Number: 1013470-200
• Device Catalogue Number: 1013470-200
• Device Lot Number: 0091041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 59