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

Model Number	B2050-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a heavily tortuous and heavily calcified iliac artery.The 5.0x40mm armada 35 balloon dilatation catheter (bdc) ruptured at an unknown pressure and during removal the bdc became stuck in the introducer.The unspecified guide catheter became broken; therefore, the introducer, guide and balloon were removed as a single unit with great difficulty.It was noted resistance with anatomy was felt during removal of the entire unit.The patient suffered moderate bleeding (dissection).It is unknown if any treatment was provided to treat the moderate bleeding.There were no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device location was not provided, and it is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The device was returned for analysis.The balloon rupture was confirmed.The difficult to remove could not be confirmed being related to circumstances of the procedure and cannot be replicated in a lab environment.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.The reported patient effect of vascular dissection is listed in the armada 35 instructions for use, as a known adverse event.Based on the information provided the cause for reported the balloon rupture, difficult to remove, and subsequent treatments /injury are related to the circumstances of the procedure.It is likely that the balloon ruptured due to interaction with the heavy calcification causing the radial tear.The radial tear would cause an enlarged profile upon retrieval as the balloon would not be in its recovered folded state causing the difficult to remove, and possibly the dissection.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the 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: 15704592
• Report Number: 2024168-2022-11137
• Device Sequence Number: 5145259
• Product Code: LIT
• UDI-Device Identifier: 08717648155178
• UDI-Public: 08717648155178
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: B2050-040
• Device Catalogue Number: B2050-040
• Device Lot Number: 20602G2
• 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: 10/13/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown