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

Catalog Number	B1100-040
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Review of the complaint history identified no other similar incidents from this lot.The armada 35 was used in a central vein.It should be noted that the armada 35 instruction for use states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries.It could not be determined if the off-label use contributed to the balloon rupture.The investigation was unable to determine a cause for the reported balloon rupture.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 10x40 mm armada 35 dilatation catheter was advanced to the moderately calcified central vein and inflated.The balloon ruptured at 11 bars of pressure with the first inflation.A non-abbott device was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information 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: 7513196
• Report Number: 2024168-2018-03578
• Device Sequence Number: 1703911
• Product Code: LIT
• UDI-Device Identifier: 08717648154942
• UDI-Public: 08717648154942
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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: 05/31/2021
• Device Catalogue Number: B1100-040
• Device Lot Number: 71219G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1