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

Model Number	B2060-200
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.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 of the reported lot revealed no other complaints.Based on the information provided, the reported balloon rupture, resistance during removal and separation were likely due to circumstances of the procedure.It is likely that the balloon rupture was the result of interaction with anatomy or associated devices.As it was reported that the balloon was inflated 2 or 3 times before rupturing at an unknown pressure, this suggests that there was no pre-existing damage to the balloon.Additionally, the resistance encountered during removal and separation likely occurred due to the ruptured balloon material catching on the introducer sheath during removal.The surgical procedure to remove the separated portion of the balloon was related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a non-calcified, non-tortuous iliac artery.The 6.0x200mm armada 35 ll balloon was inflated 2 or 3 times then the balloon ruptured at an unknown pressure.Resistance was felt during the attempted removal.The source of the resistance is unknown.Excessive force was applied then the balloon separated.The separated distal portion of the balloon was removed via surgery.There was no adverse patient sequela reported.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
• MDR Report Key: 10722049
• Report Number: 2024168-2020-08851
• Device Sequence Number: 3006412
• Product Code: LIT
• UDI-Device Identifier: 08717648155321
• UDI-Public: 08717648155321
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2020

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: 10/31/2023
• Device Model Number: B2060-200
• Device Catalogue Number: B2060-200
• Device Lot Number: 00519G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention