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

Catalog Number	B2050-020
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Estimated weight.Exemption number e2019001.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that this was a percutaneous intervention treating the left subclavian artery, moderately calcified lesion.The armada dilatation catheter advanced to the lesion and balloon inflation was performed without reported issues.Following, the balloon failed to deflate.Two different syringes (10cc and 3cc) were used to manually deflate the balloon.The balloon eventually deflated, extremely slowly (approximately 10 minutes).The device was removed without further issues.There was no adverse patient effect and there was no clinically significant delay.No additional information was provided regarding this issue.
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.Visual, dimensional and functional analysis was performed on the returned device.The reported deflation issue was not 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 indication of a lot specific product quality issue.The investigation was unable to determine a cause for the reported deflation issue.It may be possible that the kinks noted in the shaft caused the inflation/deflation lumen to become closed off while in the anatomy preventing deflation; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 9413128
• Report Number: 2024168-2019-14137
• Device Sequence Number: 4202682
• Product Code: LIT
• UDI-Device Identifier: 08717648155161
• UDI-Public: 08717648155161
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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: 08/31/2020
• Device Catalogue Number: B2050-020
• Device Lot Number: 70322G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6 FRENCH SHEATH; SUPERCORE WIRE
• Patient Age: 71 YR
• Patient Weight: 52