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

Catalog Number B1060-080

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Physical Resistance (2578); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported that the procedure was to treat a lesion in the superficial femoral artery with heavy calcification.A 6x80mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced toward the target lesion and resistance was noted due to the anatomy.During the procedure the distal shaft separated and the balloon was torn.Resistance was noted during withdrawal due to the anatomy.Therefore, minor surgery was performed and the separated distal shaft and torn balloon were successfully removed from the patient anatomy.There was a delay in the procedure.No treatment was performed on the target lesion as it was not possible to re-canalize the vessel.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).Visual inspection was performed on the returned device.The reported balloon tear and separation were confirmed.The reported resistance was unable to be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other similar incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulties and additional patient effects of surgical procedure and delay in procedure appear to be related to circumstances of the procedure.

• 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: 5598037
• MDR Text Key: 43328613
• Report Number: 2024168-2016-02573
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: B1060-080
• Device Lot Number: 50925G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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 Outcome(s): Required Intervention