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

Catalog Number B2080-060

Device Problems Off-Label Use (1494); Material Rupture (1546)

Patient Problem Perforation (2001)

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Exemption number (b)(4)-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.

Event Description

It was reported that the procedure was performed to treat a lesion in the left arteriovenous fistula.An 8x60mm armada 35 balloon catheter ruptured transversely during the second inflation at 14 atmospheres and ruptured the fistula.The fistula had to be opened and repaired surgically.There was no reported 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.It should be noted that pta, armada 35 / armada 35 ll, global, ce, costa rica instructions for use states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries.In this case, use of the armada 35 in the arteriovenous fistula did not cause or contribute to the reported balloon rupture.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 without any leak or ruptures noted, which would suggest that the device was not damaged prior to use.The investigation determined the reported balloon rupture appears to be related to circumstances of the procedure.Based on the reported information, the balloon ruptured during the second inflation at rated bust pressure of 14 atmospheres.It is likely the balloon became compromised and/or damaging against the anatomy resulting in the balloon rupture.The reported patient effects appear to be related to circumstances of the procedure as the perforation was surgically repaired.There is no indication of a product quality issue with respect to manufacture, design or labeling.It was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.

• 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: 8834107
• MDR Text Key: 152486829
• Report Number: 2024168-2019-10414
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155444
• UDI-Public: 08717648155444
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: B2080-060
• Device Lot Number: 80823G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention