MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SABER 6MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter telephone number is: (b)(6).This device is not available for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
A 6mm x 4cm x 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter was inserted and inflated the lesion; but it ruptured.Therefore, the device was replaced with a non-cordis device and the procedure was completed.There was no reported patient injury.This was a vascular access intervention therapy (vaivt) case.The device will not be returned for evaluation as it was discarded in the hospital.
Additional Manufacturer Narrative
A 6mm x 4cm x 90cm saber percutaneous transluminal angioplasty (pta) balloon catheter was inserted and inflated the lesion; but it ruptured.Therefore, the device was replaced with a non-cordis device and the procedure was completed.There was no reported patient injury.This was a vascular access intervention therapy (vaivt) case.The product was not returned for analysis because it was discarded in the hospital.A product history record (phr) review of lot 82182523 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics, although unknown and procedural factors likely contributed to the reported event.However, with the limited amount of information available regarding lesion characteristics and without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and the event reported.According to the safety information in the instructions for use ¿if resistance is met during manipulation, determine the cause of the resistance before proceeding.Balloon pressure should not exceed the rated burst pressure.The rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence), will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over pressurization.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ 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: SABER 6MM4CM 90
• 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: 10971718
• Report Number: 9616099-2020-04108
• Device Sequence Number: 791461
• Product Code: LIT
• UDI-Device Identifier: 20705032068748
• UDI-Public: 20705032068748
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 48006004S
• Device Lot Number: 82182523
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1