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

Catalog Number B1050-040

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2015

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat an occlusion in the left common iliac artery and in the distal aorta via balloon dilatation.The patient had bilateral non-abbott 6fr introducer sheaths in the groins and an armada 35 5.0 x 40 mm coming up from each side.The armada 35 coming from the right side was crossed over to the left iliac.The armada 35 going retrograde from the left side was likely subintimal with no resistance noted and a kissing dilatation was started using a non-abbott inflation device.The inflation was normal and the balloon was only inflated once within the rated burst pressure (actual pressure is not known).At deflation, normally pulling negative for 10-15 seconds, the armada 35 on the left side would not empty the contrast, so negative was pulled 1-1.5 minutes.An attempt was then made to empty the contrast using a syringe and then it was decided to pull the armada 35 out of the introducer sheath.Upon pulling it out through the introducer sheath resistance was met, bleeding started in the contrast port on the hub and it is likely that the balloon tore.The balloon did not separate and nothing remained in the patient.There was no issue noted upon removal of the protective sheath.The guide wire lumen was flushed outside of the anatomy prior to use.The balloon was not inflated with contrast prior to use.The contrast used was 100% with 240mg/ml.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Device: failure to follow instructions (contrast ratio).Evaluation summary: the device was returned for analysis.The reported deflation issue and tear or leak was unable to be confirmed.The reported difficult to remove could not be confirmed as it was based on case circumstances.Based on a visual, dimensional, and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query/review of the complaint history of the reported lot did not indicate a manufacturing issue.Based on the reviewed information, no product deficiency was identified.The armada 35 instructions for use instructs to use 60% contrast diluted 1:1 with normal saline.

• 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 462
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4723929
• MDR Text Key: 5738384
• Report Number: 2024168-2015-02265
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: B1050-040
• Device Lot Number: 50108G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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
• Treatment: INFLATION: ENCORE 26SHEATH: PRELUDE 6FR