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

Catalog Number B2060-250

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.The other armanda device is filed under separate a medwatch report.

Event Description

It was reported that the procedure was to treat two lesions with two different devices: one in the superficial femoral artery (sfa) and a second in the external iliac artery.Both lesions were heavily tortuous and heavily calcified.Both devices were prepped outside the anatomy prior to use.No issues or leaks were noted during preparation.A 6x250mm armada 35 balloon catheter was advanced without resistance toward the sfa in order to perform post dilatation of a self-expanding stent and the balloon ruptured.The armada was inflated three times up to 10 atmospheres (atm).The device was withdrawn and resistance was noted with the introducer sheath due to poor balloon refold.Excessive force was used to pull the catheter into the introducer sheath and the balloon tore.Pieces of balloon remained in the patient anatomy.A 7x100mm armada 35 balloon catheter was advanced without resistance toward the external iliac artery in order to perform post dilatation and the balloon ruptured.The armada was inflated once up to 12 atm.The device was withdrawn and resistance was noted with the introducer sheath due to poor balloon refold.Excessive force was used to pull the catheter into the introducer sheath and the balloon tore.Pieces of balloon remained in the patient anatomy.A delay in the procedure was noted.The patient was sent to surgery.Both balloon remnants were successfully removed via cut down procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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 indication of a lot specific product issue.The investigation determined that the reported difficulties, subsequent damage, surgical procedure to remove the separated balloon, and delay in procedure are related to circumstances of the procedure.Based on the information reviewed, 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: 5939274
• MDR Text Key: 54309975
• Report Number: 2024168-2016-05959
• 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: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: B2060-250
• Device Lot Number: 30929G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 74 YR