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

Catalog Number	B1080-080
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2018
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.Product performance engineering reviewed the incident information, however, the product was not returned to abbott vascular for analysis.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported balloon rupture.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 a lesion located in the basilic vein using 8 mm x 80 mm armada 35 balloon catheter for post-dilatation of a deployed stent.Reportedly, there was no resistance felt during advancement to the stent.During the first inflation of the balloon at 2 atmospheres, the balloon ruptured.Another non-abbott balloon was used to complete the procedure.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.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: 7427127
• Report Number: 2024168-2018-02746
• Device Sequence Number: 1191158
• Product Code: LIT
• UDI-Device Identifier: 08717648154881
• UDI-Public: 08717648154881
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/12/2018

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: B1080-080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 59