MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	1013470-150
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
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.(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.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents.It was reported that the balloon was inflated to 16 atmospheres.The rated burst pressure (rbp) for this device as indicated on the product label is 14 atmospheres.The armada 18 instruction for use states: inflation in excess of the rbp may cause the balloon to rupture.In this case, it could not be determined if inflating the balloon above the rbp caused the rupture.The investigation determined that the reported balloon rupture appears to be related to circumstances of the procedure.It is likely that the rupture occurred due to interaction with the lesion site.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 lesion in the superficial femoral to tibial artery with moderate calcification.A 6.0 x 150 mm armada 18 percutaneous transluminal angioplasty (pta) balloon catheter was advanced with no resistance; however, the balloon ruptured on the first inflation to 16 atmospheres.The procedure was successfully completed with an additional unspecified balloon catheter.There were no adverse patient effects and no clinically significant delay in the procedure.

• Brand Name: ARMADA 18 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: 8191844
• Report Number: 2024168-2018-10014
• Device Sequence Number: 2026654
• Product Code: LIT
• UDI-Device Identifier: 08717648208447
• UDI-Public: 08717648208447
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/21/2018

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: 07/31/2020
• Device Catalogue Number: 1013470-150
• Device Lot Number: 7021041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 59