MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO AVIATOR PLUS .014 4.0X20 142CM; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	4244020W
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record (dhr) associated with lot 17669911 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be sent in upon 30 days after receipt.
Event or Problem Description
As reported, the balloon of the 0.014¿ 4.0mm x 20mm x 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter (bc) can't be completely deflated during the deflating process and can't reach the recovery standard size.It was also noted that the device was used beyond the expiration date.There was no reported patient injury.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3,g6,h2 and h6 have been updated accordingly.As reported, the balloon of the 0.014¿ 4.0mm x 20mm x 142cm aviator plus percutaneous transluminal angioplasty (pta) balloon catheter (bc) can't be completely deflated during the deflating process and can't reach the recovery standard size.It was also noted that the device was used beyond the expiration date.There was no reported patient injury.Additional procedural details were requested but are unknown.The device was not returned for analysis.A product history record (phr) review of lot 17669911 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon deflation difficulty - partial or slow¿ was not confirmed as the device was not returned for analysis.The exact cause cannot be determined.It is likely procedural factors and handling of the device contributed to the events reported by the customer.The reported ¿packaging/pouch/box expiration date exceeded¿ was not confirmed as the device was not returned for analysis.It is unclear as to why the device was used with an exceeded expiration date as this would be against the instructions for use and is listed in the ifu as such.It is customary for staff to review the balloon size and device expiration dates prior to opening and before use.Therefore, without the return of the device for analysis, it is difficult to draw a clinical conclusion between the device and the events reported by the customer.According to the safety information in the instructions for use, ¿use the device prior to the ¿use by¿ date specified on the package.¿ according to the warnings in the safety information in the instructions for use, ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice.Failure to do so could result in air entering the vascular system.When the catheter is exposed to the vascular system, it should be manipulated only under fluoroscopy.Deflate the balloon by pulling vacuum on the inflation device, allowing adequate time for the balloon to fully deflate prior to removal.Open the hemostasis valve as wide as possible and carefully withdraw and remove the balloon catheter from the guiding catheter while keeping the guidewire in place.Close the hemostasis valve to maintain a snug seal around the guidewire.Note: in case of post-dilatation, slowly withdraw the balloon from the stent.Observe removal of the balloon under fluoroscopy to ensure that the balloon disengages from the stent.Perform angiography to confirm angioplasty and/or stent post-dilatation.Remove guidewire and guiding catheter from the patient and discard the devices.Note: if the balloon cannot be withdrawn through the guiding catheter, withdraw the balloon catheter and guiding catheter as a single unit.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: AVIATOR PLUS .014 4.0X20 142CM
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11737727
• Report Number: 9616099-2021-04480
• Device Sequence Number: 3833327
• Product Code: LIT
• UDI-Device Identifier: 20705032005743
• UDI-Public: 20705032005743
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2021

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: 4244020W
• Device Catalogue Number: 4244020W
• Device Lot Number: 17669911
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 05/07/2021
• 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: UNK.