MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number B1060-040

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure of the left superficial femoral artery (sfa) after device preparation the 6 x 40 mm armada 35 balloon dilatation catheter (bdc) was used for post-dilatation of the implanted unspecified stent, however, the balloon during the inflation attempt at 10 atmosphere (atm) appeared to not fully inflate in the middle portion.The bdc was removed from the anatomy and re-inserted for a second dilatation.The bdc was inflated at 10 atm three times for post-dilatation, but after pulling negative to go to neutral with the indeflator the balloon did not deflate.The indeflator was switched to a 60 cc syringe to facilitate deflation, but the balloon did not deflate in the anatomy.The sheath was pushed forward and the balloon was carefully and completely enclosed in the sheath while inflated without issue.After removal from the anatomy and from the sheath, it was noted that the balloon had deflated flat and was not rewrapped.No additional dilatation was performed to the vessel.There was no reported adverse patient sequela.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The reported deflation issue was unable to be confirmed.The flat balloon refold was confirmed.Based on a visual dimensional and functional analysis of the returned device, there is no indication of a product deficiency.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 reviewed information, no product deficiency was identified.

• Brand Name: ARMADA 35 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): EL COYOL, COSTA RICA REG# 3009031392; 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: 4204207
• MDR Text Key: 4978565
• Report Number: 2024168-2014-07019
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: B1060-040
• Device Lot Number: 40421G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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
• Treatment: INFLATION: INDEFLATOR