MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	A2020-080
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G9: 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 customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The 2.0x40mm armada 14 device referenced in b5 is being filed under a separate medwatch mfr number.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified lesion in the anterior tibial vein.A 2.0 x 40 mm and 2.0 x 80 mm armada balloon dilatation catheters (bdc) ruptured.One balloon was inflated once, the other balloon was inflated twice.Both were inflated to nominal pressure and both ruptured at nominal pressure.The procedure was completed after use of the devices with satisfactory results.There was no clinically significant delay in the procedure and no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001.The device was not returned for analysis.The lot history record for this product could not be reviewed and a similar complaint query could not be performed because the lot number was not reported.Based on the information provided, the balloon ruptures appears to be due to case circumstances.It is likely that the ruptures occurred due to interaction with lesion which was described as heavily calcified.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8908440
• Report Number: 2024168-2019-10957
• Device Sequence Number: 2716852
• Product Code: DQY
• UDI-Device Identifier: 08717648155970
• UDI-Public: 08717648155970
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• 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): 10/10/2019

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: A2020-080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1