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

Model Number	B1060-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified common iliac artery.The 6.0x60mm armada 35 balloon dilatation catheter (bdc) was inflated to 6 atmospheres and ruptured.Negative was pulled as device was being removed and more resistance than usual was felt.The bdc was stuck on the guide wire and would not come out of the 6fr sheath.The device separated at the balloon.The separated portion could not be removed from the patient; therefore, it was trapped against the vessel wall with an unspecified balloon-expandable stent.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for evaluation.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.In this case, it is likely that the balloon interacted with the heavily calcified anatomy such that the balloon became damaged and ruptured during inflation.Additionally, the ruptured balloon material likely became caught on the introducer sheath resulting in the reported difficulty removing the device and the reported difficulty with the guide wire and the balloon ultimately separated upon manipulation of the device, against resistance.Additional treatment was performed since the separated portion could not be removed from the patient; therefore, it was trapped against the vessel wall with an unspecified balloon-expandable stent.The investigation determined the reported complaints, device embedded in vessel or plaque and unexpected medical intervention appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified common iliac artery.The 6.0x60mm armada 35 balloon dilatation catheter (bdc) was inflated to 6 atmospheres and ruptured.Negative was pulled as device was being removed and more resistance than usual was felt.The bdc was stuck on the guide wire and would not come out of the 6fr sheath.The device separated at the balloon.The separated portion could not be removed from the patient; therefore, it was trapped against the vessel wall with an unspecified balloon-expandable stent.There was no adverse patient sequela and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported balloon rupture, difficulty removing the device from the introducer sheath and guide wire could not be replicated in a testing environment due to the condition of the returned device.The investigation determined the reported complaints, device embedded in vessel or plaque and unexpected medical intervention appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.D9- device available for evaluation updated from ¿no¿ to ¿yes¿ h3 - device returned to mfg? updated from ¿no¿ to ¿yes h6- type of investigation code 4114 'device not returned' was removed and replaced with code 10 'testing of actual/suspected device'.

• 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: 16824787
• Report Number: 2024168-2023-04406
• Device Sequence Number: 20549960
• Product Code: LIT
• UDI-Device Identifier: 08717648154706
• UDI-Public: 08717648154706
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2023

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: 03/31/2026
• Device Model Number: B1060-060
• Device Catalogue Number: B1060-060
• Device Lot Number: 21007G1
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 05/09/2023; 06/23/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/30/2023; 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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: 6FR SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 58 KG