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

Catalog Number 1013463-200

Device Problems Partial Blockage (1065); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: ht connect ; sheath: 6f x 65 cm destination sheath; other:.018 cxi support catheter.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a heavily calcified right superficial femoral artery that was 98% stenosed, and did not have any tortuosity.The lesion was accessed via the left groin and a 6f x 65 cm non-abbott introducer sheath was used.A.018 non-abbott catheter was then advanced and an unspecified non-abbott guide wire was inserted which crossed the lesion.Then this wire was switched to an unknown ht connect 250t guide wire which crossed the lesion as well.Then the non-abbott catheter was removed and a 2.0 x 200 mm armada 18 balloon catheter was advanced towards the lesion.When the connect guide wire was inserted, it could not advance through the balloon catheter.Therefore, the guide wire was switched back to the unspecified non-abbott guide wire that could not advance and cross the lesion either.The physician thought that the tip of the connect guide wire had poked through the lumen of the catheter.However, when the armada balloon catheter was removed from the anatomy, it was flushed and it was noted that the lumen was occluded, but there was no visible tearing on the catheter.Therefore, the tearing of the lumen could not be confirmed.Lastly, another unspecified armada 18 balloon catheter was used with the connect and non-abbott guide wire without any issues.Additionally, two supera peripheral stent system devices were also used to successfully complete the procedure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history records revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation was unable to determine a cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initial report, additional information was received.After the non-abbott catheter was removed, an unspecified 4.0 mm armada 18 balloon catheter was used but failed to cross the lesion due to the anatomy.Therefore, a second 2.0 x 200 mm armada 18 balloon catheter was advanced to the lesion.No additional information was provided.

• 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: 6987827
• MDR Text Key: 91365879
• Report Number: 2024168-2017-08533
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 1013463-200
• Device Lot Number: 6010441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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 Weight: 114