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

Catalog Number 1014264-200

Device Problems Inflation Problem (1310); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.The 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 de novo lesion in the mildly tortuous, moderately calcified, popliteal artery.A 5.5 x 200 mm armada 18 percutaneous transluminal angioplasty (pta) catheter was advanced with no resistance felt to the lesion and inflated to the rated burst pressure of 14 atmospheres.Once the balloon was inflated, it was observed that the balloon was not evenly inflated and there was a waist in the center of the balloon.The balloon was deflated and re-inflated and the waist was still there.The pta catheter was removed from the anatomy and the shaft in the area of balloon appeared to be kinked.A new 5.5 x 100 mm armada 18 pta catheter was used to successfully complete the procedure.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and functional inspection was performed on the returned device.The inflation issue was not confirmed.The kink was confirmed.It is likely that this damage caused the reported waist during inflation.The twisting likely occurred during positioning within the popliteal artery.It is likely that the proximal end of the catheter was twisted during advancement causing the balloon to slightly twist.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 revealed no other incidents.The investigation determined the reported difficulties appear 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 18 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): CLONMEL, IRELAND REG# 9616693; 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: 7227982
• MDR Text Key: 98763250
• Report Number: 2024168-2018-00678
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K151317
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 1014264-200
• Device Lot Number: 5090741
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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