MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number B2080-080

Device Problem Material Rupture (1546)

Patient Problem Pain (1994)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2019001.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was performed to treat the varicosis of great saphenous vein.During the procedure, an 8x80mm armada 35 balloon ruptured during the second inflation at 8 atmospheres and the patient felt severe pain.The device was immediately replaced with an unspecified one and the patient was given medications as symptomatic treatment.The patient's respiration, heartbeat, and blood pressure remained stable during the entire procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The incident information was reviewed; however, the product was not returned to abbott vascular 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 identified no other similar incidents reported from this lot.The device was prepped prior to use with no issue/ leak noted.Additionally, no balloon ruptured were reported during the first inflation which would suggest that the device was not damaged and functioning as intended.The investigation determined the reported balloon rupture appears to be related to circumstances of the procedure.Based on the reported information, it is likely the balloon became compromised and/or damaging during the first inflation against the anatomy and/or other devices used resulting in the balloon rupture during the second inflation.The reported patient effect of pain is listed in armada 35 instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect of pain, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9404895
• MDR Text Key: 177762390
• Report Number: 2024168-2019-14067
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155451
• UDI-Public: 08717648155451
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: B2080-080
• Device Lot Number: 90725G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1