MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A1040-020
Medical Device Problem Codes	Break (1069); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during device preparation, it was noted that the 4x20mm armada 14 balloon dilatation catheter (bdc) could not hold pressure.The device was then advanced to the 99% stenosed lesion in the iliac artery.Inflation was attempted in the anatomy and during inflation, it was noted that the device could not hold pressure.The bdc was removed, and the hub was noted as cracked.There was no adverse patient effect and no clinically significant delay in the procedure.A non-abbott device was used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported leak was confirmed; however, the reported break (cracked hub) could not be confirmed.It was noted that during balloon inflation at 2 atmospheres, fluid leaked out of a pinhole in the balloon a review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.It was reported by the account that physician thought that the device had already been damaged (cracked hub) from the beginning.It should be noted that the percutaneous transluminal angioplasty (pta) catheter, armada 14, global, instruction for use (ifu) states: it is very important to check before use that the packaging has not been damaged.In this case, the reported ifu violation did not cause or contribute to the reported complaint.Factors that could contribute to balloon material ruptures include, but are not limited to, balloon damage during processing of the balloon material, inflation technique, interactions with other devices or lesion calcification.In this case, a conclusive cause for the noted balloon rupture could not be determined.Furthermore, it is possible that inadvertent over torqueing of the inflation device during attempts to connect to the hub of the device, gave the impression that the hub was cracked; however, a conclusive cause cannot be determined since the complaint could not be confirmed during return analysis.The investigation was unable to determine a conclusive cause for the reported complaints.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: ARMADA 14 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, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12849552
• Report Number: 2024168-2021-10668
• Device Sequence Number: 4672067
• Product Code: DQY
• UDI-Device Identifier: 08717648155840
• UDI-Public: 08717648155840
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102705
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 07/31/2022
• Device Model Number: A1040-020
• Device Catalogue Number: A1040-020
• Device Lot Number: 9022541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2019
• 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