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

Model Number	B2070-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a restenosed and heavily calcified lesion in the common iliac artery.A 7x40mm armada 35 balloon catheter was prepared per the instructions for use.The balloon was inflated once to 6 atmospheres for 180 seconds; however, the balloon ruptured.The procedure was successfully completed with a new 7x40mm armada 35 balloon catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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 circumstances of the procedure.It is likely that the balloon rupture occurred due to interaction with heavily calcified lesion.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: 11975399
• Report Number: 2024168-2021-04865
• Device Sequence Number: 4229428
• Product Code: LIT
• UDI-Device Identifier: 08717648155352
• UDI-Public: 08717648155352
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 02/29/2024
• Device Model Number: B2070-040
• Device Catalogue Number: B2070-040
• Device Lot Number: 00908G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1