MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	1013470-200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.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 lesion in the moderately calcified, non-tortuous superficial femoral artery.Atherectomy was performed, and the 6 x 200 mm armada 18 percutaneous transluminal angioplasty (pta) catheter was advanced without resistance.The pta inflated once at six atmospheres when it ruptured.An unspecified armada 18 pta was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned.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 similar incidents reported from this lot.The investigation determined the reported balloon rupture appears to be related to circumstances of the procedure.Based on the reported information, it is likely the balloon became compromised and/or damaged during advancement against the moderately calcified anatomy and/or other devices used in the procedure resulting in the reported balloon rupture.There is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.

• Brand Name: ARMADA 18 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9104491
• Report Number: 2024168-2019-11973
• Device Sequence Number: 1971957
• Product Code: LIT
• UDI-Device Identifier: 08717648208461
• UDI-Public: 08717648208461
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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,Followup
• Report Date (Section B): 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 1013470-200
• Device Lot Number: 9042641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 09/23/2019
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 77