MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number 1014256-080

Device Problems Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/03/2022

Event Type  Injury  

Manufacturer Narrative

The device was received.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 treat a heavily calcified superficial femoral artery (sfa).During advancement the 5.0x80mm armada 18 balloon dilatation catheter (bdc) met resistance with anatomy and during the first inflation the balloon ruptured at 10 atmospheres.The bdc was removed from the unspecified sheath; however, it was noted pieces of the balloon were missing.Snaring was attempted to remove the separated pieces but was not successful; therefore, an unknown supera stent was deployed to embed the separated portions into the vessel wall.There was no adverse patient sequela; however, a clinically significant delay was reported.No additional information was provided.

Manufacturer Narrative

Visual and scanning electron microscopy (sem) inspection/analysis were performed on the returned device.The reported balloon rupture and separation were confirmed.The reported difficulty advancing the device could not be replicated in a testing environment as it was based on operational circumstances.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 identified no other similar incidents and/or complaints from this lot.The balloon was ultimately sent to the sem lab for further analysis.The sem report determined the tearing was documented at the edges of both balloon and inner member separations.The balloon exhibited longitudinal, diagonal, and radial tearing propagation.No significant mechanical damage associated with the rupture edge was observed.The rupture origin could not be identified on the proximal half of the balloon separation and may be on the distal half of the separations which was not returned for analysis.The proximal half of the inner member exhibited stretched material, tearing and a jagged edge, suggesting tensile loading.The investigation determined the reported failure to advance, balloon rupture, separation, unexpected medical intervention, device embedded in tissue or plaque and delay to treatment/therapy appear to be related to circumstances of the procedure.It was reported by the account that the bdc interacted with the heavily calcified anatomy resulting in the reported difficulty advancing the device.In this case, it is likely that the balloon interacted with the challenging anatomy, resulting in the reported balloon ruptured during inflation and subsequently the balloon material at the ruptured location became caught on the challenging anatomy and ultimately separated during retraction.Additional treatment with a snare was attempted to remove the separated pieces but was not successful; therefore, an unknown supera stent was deployed to embed the separated portions into the vessel wall.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: ARMADA 18 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13940747
• MDR Text Key: 288127977
• Report Number: 2024168-2022-03276
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/03/2022

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 Catalogue Number: 1014256-080
• Device Lot Number: 1120941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2021
• 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