MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	A2020-040
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a de novo, concentric lesion in a mildly tortuous, 99% stenosed posterior tibial artery.A 2.0x40mm armada 14 percutaneous transluminal angioplasty (pta) catheter was advanced without resistance and the balloon did not expand and was losing pressure during the first inflation.A non-abbott balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Internal file number: (b)(4).The incident information was reviewed; however, the product was not returned to abbott vascular for analysis.A review of the lot history record identified one manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.Balloon material ruptures can be affected by numerous factors such as balloon damage during processing of the balloon material, materials, inflation technique, interactions with other devices, lesion calcification and tortuosity, a previously implanted stent or insufficient preparation prior to use.The investigation was unable to determine a conclusive cause for the reported balloon rupture.It is possible that the during advancement through the mildly tortuous, 99% stenosed anatomy, the balloon became compromised or damaged resulting in the reported inflation issue due to the balloon rupture; however, this could not be confirmed.The inflation issue appears to be related to circumstances of the procedure there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8651904
• Report Number: 2024168-2019-04184
• Device Sequence Number: 265329
• Product Code: LIT
• UDI-Device Identifier: 08717648155956
• UDI-Public: 08717648155956
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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: 06/30/2020
• Device Catalogue Number: A2020-040
• Device Lot Number: 7010341
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1