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

Catalog Number 1013469-180

Device Problems Deflation Problem (1149); Difficult to Insert (1316); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was to treat a lesion in the right superficial femoral artery (sfa).An armada 18 was advanced to the lesion without resistance and the balloon was inflated without issues.However, the balloon was slow to deflate; it could visibly be seen under fluoroscopy, approximately 35 - 40 seconds it took the balloon to deflate.Once the balloon was deflated, the device was removed from the patient anatomy.An attempt was made to re-use the armada 18 for post-dilatation, but the balloon could not be inserted into the 6 fr sheath.Negative pressure was pulled and held, but the armada 18 balloon could not go through the sheath and then the balloon severely accordioned and crumpled up.The armada 18 was changed to a 5.5 x 60 mm armada 18 to complete the procedure successfully.The patient was fine.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation and the reported deflation issue was unable to be confirmed.The balloons refold and insertion issue was confirmed.Based on visual and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling.The investigation determined that a conclusive cause for the reported deflation issue difficult to insert, and balloon refold issue could not be determined.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 similar incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.(b)(4).

• 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: 5104753
• MDR Text Key: 26944373
• Report Number: 2024168-2015-05633
• 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: Health Professional
• Remedial Action: Other
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• 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: 1013469-180
• Device Lot Number: 5072441
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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 Age: 51 YR