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

Catalog Number A2040-120

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult to Remove (1528); Stretched (1601)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Estimated weight.The removed portion of the device remains with the hospital risk management and the separated portion remains in the patient's anatomy.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that this was a percutaneous interventional procedure treating a popliteal deep vein thrombosis.An armada dilatation catheter was advanced to the popliteal lesion and multiple balloon inflations were performed without issues.Following the last inflation, the balloon was unable to deflate.The indeflator was removed from the device and a syringe was attached to manually deflate the balloon.The balloon would still not deflate.A buddy wire advanced to puncture the balloon; however, this was also unsuccessful.The armada catheter was twisted and torqued, to try to remove.The unspecified wire and the distal end of the armada catheter, with the still inflated balloon, had stretched and then separated.An access needle was advanced and punctured the inflated balloon.The separated distal end of the armada, containing the balloon, and the separated wire remain in the patient's anatomy.There were no clinical symptoms.No additional information was provided regarding this issue.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.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 reported from this lot.The investigation determined the reported difficulties of deflation issue, difficulty to remove, shaft separation, stretched shaft patient effect and additional treatment appear to be related to circumstances of the procedure as an access needle was advanced and punctured the inflated balloon and the separated section of the device remains in the patient.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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): 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: 7573655
• MDR Text Key: 110227270
• Report Number: 2024168-2018-04188
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: A2040-120
• Device Lot Number: 7121241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 136