MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	1013468-200
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
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 product was not returned to abbott vascular for analysis.A review of the lot history record identified one manufacturing nonconformity associated to the reported lot that does appear to contribute to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation determined the reported leak and inflation issue appear to be related to a potential product quality issue for hub leaks.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.The issue is being addressed per internal operating procedures.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left superficial femoral artery.A 5.0 x 200 mm armada 18 percutaneous transluminal angioplasty (pta) balloon catheter was advanced to the lesion with no resistance.On the initial inflation of the balloon of the pta balloon catheter to an unknown pressure, the balloon only partially inflated and contrast / staining was noted to leak out between the shaft and hub.The pta balloon catheter was simply removed and replaced with a new unspecified armada pta balloon catheter to successfully continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 18 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: 8391223
• Report Number: 2024168-2019-01685
• Device Sequence Number: 192794
• Product Code: LIT
• UDI-Device Identifier: 08717648208249
• UDI-Public: 08717648208249
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

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: 07/31/2020
• Device Catalogue Number: 1013468-200
• Device Lot Number: 7020641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1