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

Catalog Number B1140-080

Device Problems Off-Label Use (1494); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(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 performed to treat a lesion in the common femoral vein with no calcification.A 14 x 80 mm armada 35 percutaneous transluminal angioplasty (pta) balloon catheter was advanced to the lesion for post dilatation of an unspecified stent; however, the balloon ruptured on the first inflation at 8 atmospheres.The pta balloon catheter was simply removed and an additional 14 x 80 mm armada 35 pta balloon catheter was used successfully to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was initially reported as returning for analysis, but has now been reported as not returning because it was discarded at the account.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.It should be noted that the armada 35 instruction for use states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.This device is also indicated for stent post-dilatation in the peripheral vasculature.It could not be determined if the off-label use contributed to the balloon rupture.Based on the information provided, the balloon rupture appears to be due to case circumstances.It is likely that the rupture occurred due to interaction with the lesion or associated devices causing damage to the outer surface.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
• MDR Report Key: 8091985
• MDR Text Key: 128282358
• Report Number: 2024168-2018-08978
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: B1140-080
• Device Lot Number: 80316G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 93