MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number B2040-040

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The supera device referenced is filed under a separate medwatch manufacturer report reference number.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a calcified mid left superficial femoral artery (sfa).The vessel diameter was 4 mm.A 4x40 mm armada 35 pta balloon catheter failed to inflate and leaking was noted at the hub.Reportedly, pre-dilatation was performed with a 4x40 mm armada 35 to 4.5mm with no waist or narrowing noted.A 4x80 mm supera stent did not deploy correctly 2 cm from the proximal end, twisted.The supera stent was deployed to nominal except for tight narrowing.Reportedly, there was no resistance noted with the thumbslide during deployment of the supera stent.Several attempts to post dilate the stent with a 2.5x40 mm armada 18, then a 4x40 mm armada 18, then a 5x20 mm armada 18 and finally, a 4.5x15 mm nc trek balloon dilatation catheter resolved the issue.However, the final run showed that the sfa had thrombosed.There was no reported clinically significant delay in the procedure.The patient was treated overnight with thrombolysis and discharged from the hospital.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The leak was not confirmed.It may be possible that there was a faulty connection with the syringe or inflation device, resulting in the inflation issue and leak; however, this could not be confirmed.The investigation was unable to determine a conclusive cause for the reported inflation issue and leak.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history of the reported lot revealed no other incidents.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6215686
• MDR Text Key: 63832145
• Report Number: 2024168-2016-09389
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: B2040-040
• Device Lot Number: 60618G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR