MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SABER 6MM20CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48006020X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be sent in upon 30 days after receipt.
Event or Problem Description
As reported, the 6mm x 20cm x 150cm saber balloon catheter (bc) was used, but it was found that the balloon was ruptured pointedly.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 6mm x 20cm x 150cm saber balloon catheter (bc) was used, but it was found that the balloon was ruptured pointedly.There was no reported patient injury.Additional procedural details were requested but are unknown.The product was not returned for analysis.A product history record (phr) review of lot 82185204 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.
Additional Manufacturer Narrative
Section b5: addendum for additional information has been obtained: the device was stored, handled and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was no difficulty removing the product from the hoop or difficulty removing the stylet or any of the sterile packaging components.The device did not kink or bend at any time prior to the resistance/friction.There were no kinks/bends noted after the resistance/friction was experienced.There was 50:50 contrast to saline ratio.The same indeflator was used successfully with other devices.There were kinks noted prior to inserting the product into the patient.The balloon catheter was removed easily and intact.As reported, the 6mm x 20cm x 150cm saber balloon catheter (bc) was used, but it was found that the balloon was ruptured pointedly.There was no reported patient injury.The device was not returned for analysis.The device was stored, handled, and prepped per the instructions for use (ifu).The device was prepped normally by maintaining negative pressure.There was no difficulty removing the product from the hoop or difficulty removing the stylet or any of the sterile packaging components.The device did not kink or bend at any time prior to the resistance/friction.There were no kinks/bends noted after the resistance/friction was experienced.There was 50:50 contrast to saline ratio.The same indeflator was used successfully with other devices.There were kinks noted prior to inserting the product into the patient.The balloon catheter was removed easily and intact.Additional procedural details were requested but are unknown.The device was not returned for evaluation.A product history record (phr) review of lot 82185204 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 6MM20CM 150
• 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: 11262493
• Report Number: 9616099-2021-04220
• Device Sequence Number: 10960025
• Product Code: LIT
• UDI-Device Identifier: 20705032069639
• UDI-Public: 20705032069639
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K971010
• 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,Followup
• Report Date (Section B): 03/16/2021

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: 12/31/2022
• Device Model Number: 48006020X
• Device Catalogue Number: 48006020X
• Device Lot Number: 82185204
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/09/2021; 02/19/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 02/12/2021; 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1