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

Catalog Number B2030-040

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

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2014

Event Type  malfunction  

Event Description

It was reported that during preparation of the 3.0mmx40mmx135cm armada 35 balloon dilatation catheter (bdc), air was continuously pulled, thus a leak was suspected.It was then noted that the bdc hub was cracked.The bdc was not used.Reportedly, there were no issues noted during unpackaging of the bdc prior to preparation.There was no reported patient involvement and no reported clinically significant delay in the procedure.Another 3.0mmx40mmx135cm armada 35 bdc was used to successfully complete the procedure.There was no additional information provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the returned device analysis was unable to confirm a crack but did identify a leak at the base of the hub, which was found when the balloon catheter was pressurized.A search of the complaint handling database was performed and found no other incidents identified from this lot for hub leaking issues.While a search of the lot history record for this specific lot indicated no related non-conformance records, based on an expanded investigation, a product issue related to leakage at the hub was identified.The event was possibly related to hub assembly during manufacturing.Corrective and preventative actions are in the process of being implemented.These devices will continue to be monitored.

• 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 462
• Manufacturer (Section G): BERINGEN, SWITZERLAND REG# 9710478; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4224577
• MDR Text Key: 4994205
• Report Number: 2024168-2014-07195
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: B2030-040
• Device Lot Number: 839244
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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