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

Catalog Number B1120-060

Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 09/18/2018

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: storq, amplatz super stiff.035; sheath: 8f cook medical check flo 70 cm.(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 stenotic lesion in the left jugular and brachiocephalic veins caused by tumor compression.A non-abbott 8f introducer sheath was placed and a non-abbott guide wire was advanced successfully.A 12 x 60 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced for pre-dilatation and the balloon inflated to nominal pressure.An unspecified stent was deployed and the pta balloon catheter was re-advanced with no resistance for post dilatation of the stent.The balloon was inflated three times to 8 atmospheres; however, the balloon ruptured on the final inflation.As the balloon rupture was circumferential, some resistance was met during retraction of the pta catheter in the introducer sheath, but it was able to be removed by applying some force.No balloon material remained in the anatomy.There were no adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual analysis was performed on the returned device.The reported balloon rupture was confirmed.The difficulty removing was not tested due to the condition of the device.It should be noted that the indication for use listed in the armada 35 instruction for use (ifu) 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.In this case, it could not be determined if using the armada 35 off-label contributed to the difficulties.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 incidents from this lot.The reported difficulties appear to be related to case circumstances.It is likely that interaction with the stent contributed to the rupture.The balloon was used for pre-dilatation with no difficulties reported and was also used for post-dilatation with two previous inflations prior to the rupture.This further suggests that the damage was not pre-existing and likely occurred due to case circumstances.The difficulty removing and noted separation of the balloon likely occurred when the ruptured balloon material caught on the introducer sheath during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initially filed report, the following information was received: returned goods analysis identified the balloon was separated and ruptured radially in two locations, the separated portion of the balloon was not returned.The account was unable to confirm that the separated balloon material was removed from the anatomy.No additional information was provided.

• 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: 7948984
• MDR Text Key: 123395680
• Report Number: 2024168-2018-07788
• 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: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: B1120-060
• Device Lot Number: 80314G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/09/2018
• Supplement Dates Manufacturer Received: 10/12/2018
• Supplement Dates FDA Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other