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

Catalog Number	B1050-080
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.The investigation was unable to determine a conclusive cause for the reported deflation difficulty; however the reported resistance with the stent and vessel during removal appears to be related to circumstances of the procedure.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot numbers were not provided.Based on the information reviewed, there is no indication of a product quality issue.
Event or Problem Description
It was reported that a 5.0 mm x 80 mm x 80 cm armada 35 balloon dilatation catheter (bdc) was prepped and advanced without issue to an unspecified deployed stent in the moderately calcified, moderately tortuous left superficial femoral artery (sfa) to post-dilate the stent.The armada 35 balloon was inflated without issue and post-dilatation was completed.When attempting to deflate the balloon, the unspecified inflation device showed negative pressure, but the balloon did not deflate at all.The inflation device was swapped out for a syringe and, though much force was required to pull negative pressure using the syringe, the balloon slightly deflated, but was difficult to withdraw from the stent and vessel.The partially deflated armada 35 was able to be withdrawn against resistance into the guiding catheter.Upon retraction into the guiding catheter, the armada 35 balloon partially deflated some more as it entered the distal tip of the guiding catheter and was able to be completely retracted through the guiding catheter without any resistance.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6034385
• Report Number: 2024168-2016-07013
• Device Sequence Number: 19042379
• Product Code: LIT
• UDI-Device Identifier: 08717648154621
• UDI-Public: (01)08717648154621
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: B1050-080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2016
• Initial Report FDA Received Date: 10/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR