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

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was 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 procedure was to treat a moderately tortuous and moderately calcified left subclavian artery.A 10 x 19 mm omnilink elite stent was deployed without issue.A 10 x 20 mm armada balloon catheter was inflated to 13 atmospheres for post-dilatation.There was no resistance during post-dliatation.Angiography revealed the implanted stent appeared to be fractured and some of the struts were stretched.Post-dilatation was again performed with a non-abbott balloon catheter to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Unique device identification (udi): unknown.The udi is unknown because the part number and 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.The lot history record (lhr) 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 part and lot numbers were not reported.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 the reported stent damage from the armada 35 appears to be due to operational context.Based on the reviewed information, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the devic.

• 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 5002032
• MDR Text Key: 24119166
• Report Number: 2024168-2015-04638
• 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
• Type of Report: Followup
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2015
• 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
• Patient Age: 71 YR
• Patient Weight: 60