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

Catalog Number 1014261-040

Device Problem Material Rupture (1546)

Patient Problem Embolism (1829)

Event Date 08/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a 3.0x40mm armada 18 balloon catheter failed to hold 8 atmospheres of pressure under initial inflation (ruptured).Additionally, the vessel embolized and was managed conservatively with heparin.The procedure was successfully complete with a non-abbott device.The patient spent the night in the hospital.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual and functional inspections were performed on the returned device.The connection issue was not confirmed.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 of the reported lot revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported connection issue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Return device analysis did not confirm a rupture or leak.Follow-up information was received stating: no balloon rupture was observed when the 3.0x40mm armada 18 balloon catheter was pressurized; however, the balloon would not hold pressure.It could have been a connection issue with the inflation device.Additionally, the vessel did not embolize and the patient did not spend the night in the hospital.There were no adverse patient effects.No additional information was provided.

• Brand Name: ARMADA 18 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6888546
• MDR Text Key: 87160469
• Report Number: 2024168-2017-07713
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 1014261-040
• Device Lot Number: 6112841
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention