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

Catalog Number 1013465-100

Device Problems Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional armada device referenced is being filed under a separate medwatch report.

Event Description

It was reported that the procedure was performed to treat a lesion in the left superficial femoral artery.While attempting to complete a wire exchange, resistance was met between a 3.0 x 150 mm armada 18 percutaneous transluminal angioplasty (pta) balloon catheter and two 018 non-abbott guide wires.The guide wires could not be advanced or removed to complete the wire exchange and therefore the guide wires and pta balloon catheter had to be removed as a single unit.The same problem occurred with a 3.0 x 100 mm armada 18 pta balloon catheter during the same procedure.A new wire and non-abbott balloon catheter were used to successfully continue the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction: manufacturing site.The incident information was reviewed; however, the product was not returned to abbott vascular for analysis.A review of the lot history record, database review and similar incident query for this product was not performed since the lot number was not reported.Factors that may contribute to the difficulty positioning the bdc over the guide wire and cause resistance between the devices may include, but not limited to, manufacturing damage, device placement technique, guiding catheter support, inner diameter of guide wire lumen, outer diameter of the guide wire, condition of the guide wire, or damage to the distal shaft of the catheter.The investigation was unable to determine a conclusive cause for the reported difficulty to position or remove.Based on the information reviewed, 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
• MDR Report Key: 8483246
• MDR Text Key: 140921544
• Report Number: 2024168-2019-02635
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013465-100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: V18, 018 GUIDE WIRE; GUIDE WIRE: V18, 018 GUIDE WIRE