MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B1140-060
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Codes	Tachycardia (2095); Foreign Body In Patient (2687)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) 2023 h6: medical device problem code 1494 off-label use manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.
Event or Problem Description
It was reported that the procedure was to treat the left iliac vein.The 14x60 mm armada percutaneous transluminal angioplasty (pta) catheter was inflated three times to 11 atmospheres but the balloon ruptured.The device was fully deflated upon removal; however, the device became stuck on the end of the introducer sheath in the right internal jugular vein during removal.A knife was used to cut the flush port of the device and then the access sheath was removed.A larger sheath was then attempted and the distal marker of the balloon was able to be captured.When the device was retrieved, it was inspected and it was found that some of the balloon material had separated, about 1-5 mm of material.An angiogram was performed and a cava-gram.Intravascular ultrasound (ivus) was also performed and a focused scan of the neck, and no debris or foreign body was seen; however, a small fragment likely remains in the patient.A bedside echocardiogram was performed as there was sinus tachycardia which occurred related to guide wire and catheter manipulation.The patient was held for observation but they are well and asymptomatic.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported balloon rupture and separation were confirmed.The reported difficulty to remove could not be replicated in a testing environment 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 identified no other similar incidents and/or complaints from this lot.It was reported that the procedure was to treat the left iliac vein.It should be noted the percutaneous transluminal angioplasty catheter (pta), armada 35 / armada 35 ll, global, 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.This device is also indicated for stent post-dilatation in the peripheral vasculature.In this case, it is unknown if the ifu violation contributed to the reported compliant.The reported patient effect of tachycardia is listed in the percutaneous transluminal angioplasty (pta) catheter, armada 35 / armada 35 ll, global, instruction for use (ifu) as a known patient effect.The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported difficulty removing the device, separation, foreign body in patient, hospitalization and unexpected medical intervention are likely due to circumstances of the procedure.A conclusive cause for the reported patient effect of tachycardia and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat the left iliac vein.The 14x60 mm armada percutaneous transluminal angioplasty (pta) catheter was inflated three times to 11 atmospheres but the balloon ruptured.The device was fully deflated upon removal; however, the device became stuck on the end of the introducer sheath in the right internal jugular vein during removal.A knife was used to cut the flush port of the device and then the access sheath was removed.A larger sheath was then attempted and the distal marker of the balloon was able to be captured.When the device was retrieved, it was inspected and it was found that some of the balloon material had separated, about 1-5 mm of material.An angiogram was performed and a cava-gram.Intravascular ultrasound (ivus) was also performed and a focused scan of the neck, and no debris or foreign body was seen; however, a small fragment likely remains in the patient.A bedside echocardiogram was performed as there was sinus tachycardia which occurred related to guide wire and catheter manipulation.The patient was held for observation but they are well and asymptomatic.Subsequent to the initially filed report it was reported that the access site was the right internal jugular.The patient remains on pre-planned therapeutic anticoagulant.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18117103
• Report Number: 2024168-2023-12557
• Device Sequence Number: 15172121
• Product Code: LIT
• UDI-Device Identifier: 08717648155031
• UDI-Public: 08717648155031
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: B1140-060
• Device Lot Number: 21128G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 11/11/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 23CM 10CH SHEATH
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown