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

Catalog Number 1014256-200

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2015

Event Type  Malfunction  

Event Description

It was reported that the procedure was to treat a lesion in the mid left superficial femoral artery with mild calcification. The 5. 0 x 200 mm armada 18 balloon catheter was advanced and inflated 5 times to rated burst pressure (rbp); however, it was observed that the proximal balloon shoulder extended farther than expected from the proximal balloon marker. The procedure was then completed. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

(b)(4). It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed. A review of the lot history record revealed no non-conformances that would have contributed to the reported event. A query of the electronic complaint handling database revealed no other similar incidents reported from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling. The armada 18 is currently not commercially available in the u. S. ; however, it is similar to a device sold in the u. S.

• 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 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4806268
• MDR Text Key: 16179648
• Report Number: 2024168-2015-03034
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: GM
• PMA/PMN Number: K121352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: HEALTH PROFESSIONAL
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 05/29/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 02/28/2017
• Device Catalogue Number: 1014256-200
• Device LOT Number: 5033141
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Date Manufacturer Received: 05/06/2015
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 03/01/2015
• 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: 05/29/2015 Patient Sequence Number: 1

Treatment

SHEATH: 6F TERUMO DESTINATION