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

Catalog Number B1100-040

Device Problems Detachment Of Device Component (1104); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual inspection was performed on the returned device.The reported balloon rupture and separation were confirmed.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 identified no other similar incidents from this lot.The investigation determined that the reported difficulties were due to case circumstances.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 procedure was to treat a clot in the right femoral / right common iliac vein.Catheter assisted thrombolysis (ekos) was used.Post ekos, an armada 35 10 mm / 40 mm balloon was advanced from femoral to iliac vein.The armada was inflated twice and ruptured at 12 atmospheres near the previously implanted stents in the iliac vein.Angiography showed the distal end of the balloon was knotted and stuck on the guide wire and half the balloon was in the guiding catheter.The knotted portion of the balloon that was stuck on the guide wire was eventually safely removed when the sheath was upsized to a 14 french.Nothing was ever free-floating.The device was prepped according to the ifu.There was no resistance noted during advancement in the anatomy.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

• 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: 7223353
• MDR Text Key: 98774936
• Report Number: 2024168-2018-00638
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154942
• UDI-Public: 08717648154942
• 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
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: B1100-040
• Device Lot Number: 70522G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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 Age: 35 YR
• Patient Weight: 69