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

Model Number	B2050-040
Medical Device Problem Codes	Deflation Problem (1149); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001- permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Date of event has been estimated.
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion.A 5.0 x 40 mm armada 35 balloon dilatation catheter remained inflated for an extended period of time even after 3 attempts of deflation.It is unknown how the device was removed.Another balloon was used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
Device code 2017- incorrect contrast.Visual, dimensional and functional analysis was performed on the returned device.The reported deflation issue was not confirmed.It should be noted that the armada 35 instruction for use, instructs to use 60% contrast diluted 1:1 with normal saline.In this case, it could not be determined if the contrast ratio contributed to the deflation difficulty as the contrast was mixed 5ml contrast to 10ml serum.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 indication of a lot specific product quality issue.The investigation was unable to determine a cause for the reported deflation issue.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat an unspecified lesion.A 5.0x40mm armada 35 balloon dilatation catheter remained inflated for an extended period of time even after 3 attempts of deflation.It is unknown how the device was removed.Another balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.9/30/2019: additional information was received stating: the balloon was used to treat a limb angioplasty.The balloon ultimately deflated after more than 2 minutes.No additional information was provided.

• 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: 9109522
• Report Number: 2024168-2019-12023
• Device Sequence Number: 16921266
• Product Code: LIT
• UDI-Device Identifier: 08717648155178
• UDI-Public: 08717648155178
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2020

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: 03/31/2020
• Device Model Number: B2050-040
• Device Catalogue Number: B2050-040
• Device Lot Number: 61026G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 01/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR