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

Catalog Number B2060-040

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the patient presented with a thrombosed lesion in the common femoral artery (cfa) with a plan to perform thrombectomy and stenting with a non-abbott stent after pre-dilating the lesion with a 6.0mm x 40mm x 135cm armada 35 balloon dilatation catheter (bdc).After prepping the armada 35 bdc per its instructions for use without issue, the armada 35 bdc was advanced over a non-abbott guide wire to the lesion without resistance.During inflation, the balloon ruptured below its rated burst pressure, resulting in balloon separation in multiple places (four pieces total) with the balloon pieces still threaded over the guide wire; exiting of contrast from the balloon was visualized.Reportedly, the balloon rupture and separation did not exacerbate the existing thrombosis.After balloon rupture, the inner member of the armada was stuck on the guide wire and was, thus, unable to be retracted.Both devices were withdrawn as a single unit without further difficulty.Pre-dilatation was completed using another armada 35 bdc without issue.As planned, thrombectomy was performed and the physician confirmed that no balloon pieces were left in patient vasculature or present in the aspirated thrombus.The procedure was completed via placement of the non-abbott stent as planned.There were no adverse patient effects and there was no occurrence of a clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).Pt identification: correction: (b)(6).Evaluation summary: visual inspection and scanning electron microscopy analysis were performed on the returned device.The reported balloon rupture was confirmed and separation was confirmed.The difficulty removing was unable to be tested due to the condition of the returned device.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 identified no other similar incidents from this lot.The investigation determined that a conclusive cause for balloon rupture could not be determined.However, the difficulty removing and separation was due to case circumstances.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: 6432003
• MDR Text Key: 71060125
• Report Number: 2024168-2017-02486
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111899
• 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: 04/12/2017

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: 10/31/2019
• Device Catalogue Number: B2060-040
• Device Lot Number: 60531G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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
• Treatment: GUIDE WIRE: GLIDEWIRE