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

Catalog Number B2050-040

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was reported to be 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 armada 35 was being prepped according to the instruction for use; however, negative pressure could not be pulled.A crack in the hub was suspected.A new armada 35 was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Ate of event - estimation corrected because it reportedly occurred in (b)(6) 2015.(b)(4)- a partial udi is being reported because the lot number was not provided.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.Based on the reported information, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that a conclusive cause for the leak and/or crack could not be determined.The lot history record for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture or labeling.

• 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: 5004694
• MDR Text Key: 24200699
• Report Number: 2024168-2015-04659
• Device Sequence Number: 1
• Product Code: LIT
• 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
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B2050-040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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