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

Model Number	B2140-020
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion.A 14x20mm armada 35 balloon was inflated and ruptured at an unspecified atmosphere.Two other unspecified balloons were used but also ruptured.A 4th unspecified balloon was used to successfully complete the procedure.A delay of less than 30 minutes was noted but no adverse patient effects were reported.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion.A 14x20mm armada 35 balloon was inflated and ruptured at an unspecified atmosphere.Two other unspecified balloons were used but also ruptured.A 4th unspecified balloon was used to successfully complete the procedure.A delay of less than 30 minutes was noted but no adverse patient effects were reported.No additional information was provided.Additional information received subsequent to filing the initial mdr: the procedure was to treat a heavily calcified aorto iliac lesion.The account confirmed that there were no adverse patient effects due to the 30 minute delay.Only one inflation at 8 atmospheres was performed.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported balloon rupture was confirmed.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 complaints.The investigation determined that the reported difficulties were likely due to case related circumstances.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
• MDR Report Key: 9618431
• Report Number: 2024168-2020-00839
• Device Sequence Number: 10899491
• Product Code: LIT
• UDI-Device Identifier: 08717648155581
• UDI-Public: 08717648155581
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: B2140-020
• Device Catalogue Number: B2140-020
• Device Lot Number: 90718G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 01/02/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1