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

Catalog Number B2060-040

Device Problems Leak/Splash (1354); Difficult to Remove (1528); Material Separation (1562)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 02/07/2019

Event Type  Injury  

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: terumo advantage 0.035.Stent: 8x80 covera, begraft.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 totally occluded lesion in the iliac artery.Following recanalization, a 6x40mm armada 35 balloon catheter was used to pre-dilate the lesion.An 8x80mm non-abbott covered stent failed to cross due to the bifurcation and was removed.The balloon catheter was re-advanced for additional pre-dilatation; however, after dilatation the balloon became stuck with the anatomy and was not able to move forward or backwards.It was noted that the balloon catheter became damaged because blood was noted in the lumen.A puncture on the other groin was made to advance the guide wire into an introducer sheath and remove the catheter from the other side, but the guide wire was also stuck in the balloon catheter.The guide wire was pulled very hard with forceps while the balloon catheter was held down.A jolt was felt and the resistance lessened.The balloon catheter and half of the balloon came out.The remaining part of the balloon stayed in the common iliac.Several attempts were made to snare the separated balloon portion, but were unsuccessful.The balloon was covered with a peripheral stent graft.The patient is doing well.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: visual analysis was performed on the returned device.The reported separation was confirmed.The difficulty removing was not tested due to the condition of the returned device.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 revealed no other incidents.The investigation determined the reported difficulties were likely due to challenging case circumstances.The separation noted to the balloon and inner member on the returned device likely occurred while attempting to advance and retract through the totally occluded lesion.It is likely that the balloon became lodged within the occlusion resulting in separation during the attempt to remove.It was reported that the armada 35 was used for pre-dilatation suggesting that the damage was not pre-existing and occurred during the second advancement attempt for additional pre-dilatation.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: 8401411
• MDR Text Key: 138157071
• Report Number: 2024168-2019-01791
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: B2060-040
• Device Lot Number: 81019G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Date Manufacturer Received: 04/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention