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

Catalog Number 1014256-180

Device Problems Inflation Problem (1310); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2017

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.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other armada device referenced is filed under a separate medwatch report.

Event Description

It was reported that the patient underwent a procedure, treating a target lesion in the left superficial femoral artery (sfa).The lesion was pre-dilated.A 5.0 x 200 mm supera stent was implanted and a 5.0 x 180 mm armada 18 dilatation catheter was advanced for post-dilatation.The balloon was inflated; however, it was noted that the mid portion of the balloon did not inflate and the balloon had a waist.The device was removed and a second 5.0 x 180 mm armada 18 dilatation catheter was advanced to the site and the balloon was inflated.This device also did not inflate in the mid portion of the balloon.The balloons seemed to be twisted around the shaft in the mid portion and not able to open at that particular spot.The physician was able to use the armada 18 dilatation catheters for post-dilatation and there was no adverse patient effect.There was no clinically significant delay.No additional information was provided.

Manufacturer Narrative

Internal file number - 323795/1-2.Evaluation summary: visual and functional inspections were performed on the returned device.The inflation issue and irregular appearance were 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 determined that the reported difficulties were due to operational context and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• 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: 6679802
• MDR Text Key: 78830827
• Report Number: 2024168-2017-05543
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 1014256-180
• Device Lot Number: 5071441
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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
• Treatment: SHEATH: 6 FRENCHSUPERA STENT