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

Catalog Number B1060-150

Device Problems Kinked (1339); Physical Resistance (2578); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: radifocus 0.035" 180cm; guide catheter: destination 6f 45cm.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a lesion located in the superficial femoral artery with no tortuosity.Resistance was felt during advancement of a 6.0x150mm armada 35 balloon dilatation catheter (bdc) to the lesion and crossed successfully.The bdc was inflated twice at 6atm (total dilatation time was 600 seconds) without issues; however after the bdc was removed from the anatomy, the inner member of the balloon was observed to be kinked and stuck out from the balloon material.No deflation issue was reported, the balloon deflated completely prior to removal.No additional treatment was performed to the target lesion.There were no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 6442585
• MDR Text Key: 71334067
• Report Number: 2024168-2017-02625
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: B1060-150
• Device Lot Number: 60307G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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: 66 YR
• Patient Weight: 74