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

Catalog Number	B2070-020
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/05/2019
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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of the complaint history identified no other similar incidents reported from this lot.Factors that may contribute to leaks or air during preparation include, but are not limited to, manufacturing, damage to the sidearm/inflation lumen, inflation lumen blockage, damage to the shaft, damage to the balloon or a loose connection.The investigation was unable to determine a conclusive cause for the reported inability to prep properly or balloon rupture.Return of the device may have further aided the analysis.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 before use, during prep, the physician didn't feel correct tension on inflation device of the armada 35 7mm/20mm percutaneous transluminal angioplasty (pta) catheter.It was brought to the back table and inflated and ruptured at 6 atmospheres.Reportedly, the device was prepped correctly per the instructions for use (ifu), but the balloon didn't feel right and didn't seem like it was prepping correctly.The device was not used and there was no patient involvement.A new armada 35 was used to successfully complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.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: 8735525
• Report Number: 2024168-2019-05113
• Device Sequence Number: 19400819
• Product Code: LIT
• UDI-Device Identifier: 08717648155345
• UDI-Public: 08717648155345
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2019

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 Expiration Date: 04/30/2022
• Device Catalogue Number: B2070-020
• Device Lot Number: 81113G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1