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

Catalog Number 1013465-200

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information. The guidewire is filed under a separate medwatch report.

Event Description

It was reported that the procedure was to treat an acute clot in the mildly calcified, anterior tibial artery. The 3. 0mm x 200mm x 150 cm armada 18 otw balloon dilatation catheter (bdc) was advanced without issue and was inflated for three minutes. Once deflated, the bdc was removed without resistance. However, upon removal, it was noted that the balloon had detached from the catheter and remained in the anterior tibial. The balloon was retrieved with a snare device. Although there was a delay in the procedure it did not result in significant impact to the patient. There were no adverse patient effects. Returned device analysis revealed the innermember was separated and was returned stuck on an unknown abbott guide wire. The guide wire was added as part #2 of this event. No additional information was provided.

Manufacturer Narrative

(b)(4). The returned guide wire was a non-abbott guide wire. A visual inspection was performed on the retuned device. The reported balloon separation was 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 reported from this lot. The investigation determined the reported balloon separation and subsequent damages to the inner/outer member and dispenser coil appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initially filed report, the following information was received: the returned guide wire is not an abbott guide wire. A snare device was unsuccessful in retrieving the balloon; therefore, the balloon dilation catheter (bdc) was re-wired with a non-abbott guide wire, and the balloon was retrieved. No additional information was provided.

• 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: 7430540
• MDR Text Key: 105505231
• Report Number: 2024168-2018-02780
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 1013465-200
• Device Lot Number: 7112041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/13/2018 Patient Sequence Number: 1