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

Catalog Number B1060-060

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The right iliac was successfully stented with a 7x100mm non-abbott stent being placed over the omnilik elite from the aortoiliac bifurcation to the external iliac artery.The situation worsened as the right side was opened, but there was no flow due to manipulations with the 7f introducers and the 8f sheath.The case was completed with manual compression to the right common femoral artery due to the calcification, which caused a cuff-miss to occur when a proglide was used.After a day the patient had to undergo surgery as the stents were again occluded.The occlusion was a mixture of thrombosis and mesh.The patient is doing well after undergoing surgery.No additional information was provided.Medical devices: guide wire: storque 35 cordis, sheath: cordis 7f, stent: 7x59mm omnilink elite.Device coding: (b)(4) above rated burst pressure (rbp).The 7x59mm omnilink elite and proglide devices referenced in b5 are being filed under separate medwatch reports.Evaluation summary: visual inspections were performed on the returned device.The reported balloon rupture and balloon separation was confirmed.The instructions for use states: inflation in excess of the rated burst pressure may cause the balloon to rupture.It is likely that inflating the balloon above the rbp contributed to the balloon rupture and separation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported balloon rupture, balloon separation and treatment appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a 100% stenosed and heavily calcified restenosed lesion in the external iliac artery.Following pre-dilatation, a 7x59mm omnilink elite stent was implanted.The stent had 15% residual restenosis; therefore, a 6x60mm armada 35 balloon catheter was advanced and inflated past the rated burst pressure to fully appose the stent.The balloon ruptured circumferentially.During an attempt to remove the ruptured balloon parts of the balloon became stuck with the struts of the implanted stent and caused the balloon catheter to separate.The proximal part of the balloon catheter was removed.To remove the entrapped distal portion of the balloon, a non-abbott wire was advanced on the left side and an 8f introducer was crossed over to the right common iliac artery.The non-abbott wire was pulled through from left to right; however, the tip of the wire got stuck in the previous implanted stent resulting in stent struts becoming flared.An unknown 5mm dilatation catheter was advanced via the left side and while performing successive dilatation of the balloon, the separated distal part of the armada 35 balloon catheter was removed from the stent struts.The separated part of the balloon was then fixed using a 70cm-6f-sheath from the right side and an 8f sheath from the left side.Via a long maneuver with push and pull, the separated part of the balloon catheter was removed through a 7f into the 8f sheath out of the body.

• 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: 7039695
• MDR Text Key: 92285180
• Report Number: 2024168-2017-09052
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154706
• UDI-Public: 08717648154706
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: B1060-060
• Device Lot Number: 70726G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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
• Patient Outcome(s): Required Intervention