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

Catalog Number	B2060-100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device was not returned for analysis.A review of the lot history record revealed one manufacturing nonconformity that is not related to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure, as it is likely that the rupture occurred due to interaction with lesion calcification which is described as heavily calcified left superficial artery.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacturing, design or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the heavily calcified left superficial femoral artery.The 6.0 x 100 armada 35 dilatation catheter was advanced to the target lesion.The balloon was inflated to 16 atmospheres (atm) and a balloon rupture occurred.The device was removed from the anatomy without difficulty.There was no adverse patient effect.A second armada 35 dilatation catheter was used without issue.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: 9492510
• Report Number: 2024168-2019-14722
• Device Sequence Number: 19136466
• Product Code: LIT
• UDI-Device Identifier: 08717648155291
• UDI-Public: 08717648155291
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/18/2019

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: 07/31/2022
• Device Catalogue Number: B2060-100
• Device Lot Number: 90218G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1