MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number F2012-020

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2016

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 is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported the procedure was to treat a de novo lesion mild tortuosity and heavy calcification in the mid anterior tibial artery.The 2.5 x 200 mm armada 14 balloon was used 2 times; however, was not able to advance for a 3rd inflation due to the balloon being crinkled [bunched] and resistance with the sheath.There was also resistance with sheath during removal of the balloon catheter.A new device of the same size was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual dimensional and functional analysis was performed on the returned device.The reported refold issue and resistance with the introducer sheath were not confirmed.It is possible that the balloon folds and profile dimensions became compromised after the first and second inflations and removals; 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 identified no other similar incidents from this lot.The investigation was unable to confirm the reported difficulties and a conclusive cause was not determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Correction: the device used in this case was a 1.2x20mm armada 14, not a 2.5x200mm armada 14 as initially reported.No additional information was provided.

• Brand Name: ARMADA 14 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: 6175580
• MDR Text Key: 62716185
• Report Number: 2024168-2016-08874
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K102705
• 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: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: F2012-020
• Device Lot Number: 60127G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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
• Treatment: SHEATH: CORDIS 5F