MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	B1060-060
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned.Analysis is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the femoral artery.The 6.0x60mm armada 35 balloon dilatation catheter (bdc) was advanced to the lesion.Air aspiration was performed in the anatomy before dilatation, however; blood was observed in the hub therefore a leak was suspected and the bdc was removed.A non-abbott device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and functional inspections were performed on the returned device and the reported leak was confirmed via sem analysis.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 incidents and/or complaints reported from this lot.Possible factors that can contribute to hub leak include, but are not limited to, manufacturing, damage to the sidearm/inflation lumen, insufficient/delamination of the adhesive at the inflation lumen/sidearm junction, accessory devices or loose connection with the inflation device.It should be noted that the instructions for use (ifu), pta, armada 35 / armada 35 ll, global, ce, costa rica states: express all air and leave the catheter under negative pressure until the balloon is at the target lesion site.Additionally, place the prepared catheter over a pre-positioned guide wire and advance the tip to the introduction site.In this case the reported ifu violation did not cause or contribute to the reported hub leak.Based on the sem analysis, the investigation has determined that the reported leak is not related to a potential product quality issue as the occurrence rate is within the acceptable range of the risk assessment.Addtl mfg narrative.
Additional Manufacturer Narrative
H6: device code 2017- failure to follow steps / instructions.A visual and functional inspections were performed on the returned device and the reported leak 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 incidents and/or complaints reported from this lot.It should be noted that the armada 35 / armada 35 ll instructions for use (ifu) states: express all air and leave the catheter under negative pressure until the balloon is at the target lesion site.Additionally, place the prepared catheter over a pre-positioned guide wire and advance the tip to the introduction site.In this case the reported ifu violation did not cause or contribute to the reported hub leak.Possible factors that can contribute to hub leak include, but are not limited to, manufacturing, damage to the sidearm/inflation lumen, insufficient/delamination of the adhesive at the inflation lumen/sidearm junction, accessory devices or loose connection with the inflation device.The investigation has determined that the reported leak is not related to a potential product quality issue as the occurrence rate is within the acceptable range of the risk assessment.Na.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10852866
• Report Number: 2024168-2020-09602
• Device Sequence Number: 3489379
• Product Code: LIT
• UDI-Device Identifier: 08717648154706
• UDI-Public: 08717648154706
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2020

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 Expiration Date: 05/31/2023
• Device Model Number: B1060-060
• Device Catalogue Number: B1060-060
• Device Lot Number: 91210G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 12/15/2020; 12/15/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 12/15/2020; 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1