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

Catalog Number B1080-040

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 09/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Visual analysis was performed on the returned device.The reported balloon rupture and separation were confirmed.The difficulty removing was not tested due to the condition of the device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Review of the complaint history identified no other similar incidents from this lot.The investigation determined that the reported difficulties and subsequent patient effects were likely due to case circumstances.It is likely that the balloon rupture occurred due to interaction with the anatomy which was described as heavily calcified.The resistance and separation during removal likely occurred as the ruptured balloon material caught in the sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the armada 35 was easily advanced to the non-tortuous, moderate to heavily calcified, right common iliac artery.Post dilatation of the non-abbott stent was performed one time with the armada.When the armada was being taken to rated burst pressure, the balloon burst and the armada could not be removed from the anatomy.The sheath size was up-sized to 11 french, and the armada was removed with much difficulty.During attempt to remove, a segment of the armada balloon separated.The separated piece was removed percutaneously using another balloon dilatation catheter from the left side.There was quite a bit of bleeding around the sheath access site at the femoral artery.Endarterectomy was performed and a patch was placed to treat arterial damage done by the large sheath.The patient is doing fine.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: cine images were provided and reviewed by an abbott vascular clinical specialist.The results are as follows: imaging shows what appears to be a balloon that has ruptured as well as the recovery process the physician employed.There does not appear to be any conclusive evidence for the root cause of the failure based upon the images and report.

• 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: 7923793
• MDR Text Key: 122253564
• Report Number: 2024168-2018-07550
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154867
• UDI-Public: 08717648154867
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: B1080-040
• Device Lot Number: 71110G2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/01/2018
• Supplement Dates Manufacturer Received: 10/08/2018
• Supplement Dates FDA Received: 10/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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
• Treatment: STENT: COVERED LIFESTREAM: 7.0X26 MM, 7.0X37 MM
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 57