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

Catalog Number B1040-060

Device Problems Inflation Problem (1310); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Visual and functional inspections were performed on the returned device.The inflation issue and irregular balloon fold was not confirmed.It may be possible that the kinked inner member contributed to the inflation issue while in the anatomy preventing the balloon from inflating; however, this could not be 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 difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion in the common iliac artery.A 4.0x60mm armada 35 balloon catheter was advanced to the lesion.An attempt to inflate the balloon was made; however, the balloon dilated irregularly and the positioning part was not dilated (the dilated part was about 10mm distal to the positioning part).The device was removed and it was confirmed that the balloon was fold at the front end portion against the balloon marker.The procedure was successfully completed without additional treatment.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: ARMADA 35 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): EL COYOL, COSTA RICA REG# 3009031392; 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: 6549481
• MDR Text Key: 74656038
• Report Number: 2024168-2017-03980
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154522
• UDI-Public: (01)08717648154522(17)171031(10)40521G1
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: B1040-060
• Device Lot Number: 40521G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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