MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B2070-080
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.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 similar incidents.Based on the information provided, the balloon rupture appears to be due to case circumstances.It is likely that the rupture occurred due to interaction with the heavily calcified lesion.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a 95% stenosed and heavily calcified lesion in the superficial femoral artery.After nine passes of atherectomy were performed, the 7.0x80mm armada percutaneous transluminal angioplasty (pta) catheter was then advanced without resistance and inflated an unknown number of times when the balloon ruptured.The rated burst pressure was unknown but was noted to be at or below nominal.The device was removed without reported issue and replaced with another armada 35 pta catheter to successfully complete the procedure.There was no adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8621583
• Report Number: 2024168-2019-03923
• Device Sequence Number: 13548440
• Product Code: LIT
• UDI-Device Identifier: 08717648155376
• UDI-Public: 08717648155376
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2019

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: 03/31/2021
• Device Catalogue Number: B2070-080
• Device Lot Number: 71025G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 100