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

Catalog Number B2040-040

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2016

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: terumo stiff 0.35 (x2), sheath: cook flexor 6f 55cm.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 procedure was to treat a de novo lesion in the proximal left superficial femoral artery (sfa) that was occluded for 5 cm after the ostium.The vessel was also heavily calcified.A non-abbott guide wire was angled and positioned.There was no device issues noted during prep of the armada 35 4 x 40 mm balloon catheter.Once inside the patient, the armada balloon had difficulty advancing on the guide wire and would not advance any further.It was also very difficult to remove the guide wire from the balloon lumen for exchange.Another non-abbott guide wire was then advanced in the balloon lumen with the same resistance felt.The balloon was ultimately removed and a non-abbott balloon was then advanced on the same guide wire without any resistance.The procedure was successfully completed.There were no adverse effects and no clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The device was returned for evaluation and the reported resistance was unable to be confirmed.Based on visual, dimensional, and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling.A conclusive cause for the reported resistance could not be determined.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 incidents from this lot.Based on the reviewed information, there is no indication the issue was caused by, or related 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: 5442369
• MDR Text Key: 38704374
• Report Number: 2024168-2016-00918
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: B2040-040
• Device Lot Number: 50820G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• 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
• Patient Age: 96 YR