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

Catalog Number	B2100-060
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.It may be possible that the balloon became entrapped within the vessel causing the separation during removal; however, this could not be confirmed.Without having the device to examine, the investigation was unable to determine a conclusive cause for the reported difficulties.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 of the reported lot revealed no other incidents.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
The following information is from a user facility medwatch report: per rn description: armada 35 pta catheter detached within patient.The balloon was inflated then deflated and when dr.Was moving the device out it snapped apart leaving half of the balloon inside the patient.The balloon was able to be removed.Per md: the patient did have an occlusion of the innominate vein with small collaterals filling that region.The decision was made to intervene.We upsized the sheath to a 7-french sheath and crossed the lesion with a berenstein catheter as well as a glidewire.After this was crossed, we then used a 6 x 200 mm armada balloon to balloon the entire region.We then used an 8 x 80 armada balloon without good success and we upsized to a 10 x 60 armada balloon.The armada balloon was taken down, and while withdrawing the armada balloon, the proximal portion of the balloon became disrupted and was only partially removed.The remaining distal portion was still on the wire.We then upsized the sheath to a 10-french sheath and used buddy wire technique to snare the rosen wire and removed the entire apparatus.We then placed pressure over the wound, used 4-0 monocryl to close the subcuticular layer over this and we applied venous pressure for greater than 15 minutes.This was then hemostatic.The balloon was evaluated and all the balloon was removed after the snare technique.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6589803
• Report Number: 2024168-2017-04465
• Device Sequence Number: 1278418
• Product Code: LIT
• UDI-Device Identifier: 08717648155178
• UDI-Public: (01)08717648155178(17)200131(10)60830G1
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: B2100-060
• Device Lot Number: 60830G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2017
• Initial Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 102