MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO SABER 2.5MM15CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48002515X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of 2.5mm x 15cm 150 saber percutaneous transluminal angioplasty (pta) balloon dilatation catheter ruptured before reaching nominal pressure.Therefore, a new unknown balloon was opened, and case resumed.There was no reported patient injury.The operator was trained to the saber balloon catheter.The device was opened in sterile field.The device will be returned for evaluation.
Additional Manufacturer Narrative
As reported, the balloon of 2.5mm x 15cm 150 saber percutaneous transluminal angioplasty (pta) balloon dilatation catheter ruptured, at four atmospheres, before reaching nominal pressure.Therefore, a new unknown balloon was opened, and case resumed.There was no reported patient injury.The operator was trained to the saber balloon catheter.The device was opened in sterile field.The target lesion is the anterior tibial with severe calcification and ninety percent stenosis.There was no difficulty noted in the balloon during prep.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.A competitor's contrast media and inflation device were used with a 50/50 contrast to saline ratio.The inflation device was successfully used with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The catheter has never been in an acute bend.The product removed intact (in one piece) from the patient.No other information was provided.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82203701 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon- burst - at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of severe calcification with and 90% stenosis, likely contributed to the reported event, as calcification is known to damage balloon material.However, without the return of the device for analysis it is difficult to draw a clinical conclusion between the device and event reported.According to the warnings in the safety information in the instructions for use ¿prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.To reduce the potential for vessel damage or the risk of dislodgement of particles it is very important that the inflated diameter of the balloon should approximate the diameter of the vessel just proximal and distal to the lesion.The balloon dimensions are printed on the product label.The compliance table incorporated with the product shows how balloon diameter increases as pressure increases.Do not exceed the rated burst pressure recommended on the label.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.Pressure in excess of the rated burst pressure can cause balloon rupture and potential inability to withdraw the catheter through the introducer sheath.Balloon rupture can cause vessel damage and the need for additional intervention.Use only the recommended balloon inflation medium (a 50/50 mixture by volume of contrast medium and normal saline).Never use air or any gaseous medium to inflate the balloon.¿ 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
Additional information was received and section b5 (description of event) was updated below: as reported, the balloon of 2.5mm x 15cm 150 saber percutaneous transluminal angioplasty (pta) balloon dilatation catheter ruptured, at four atmosphere, before reaching nominal pressure.Therefore, a new unknown balloon was opened, and case resumed.There was no reported patient injury.The operator was trained to the saber balloon catheter.The device was opened in sterile field.The target lesion is the anterior tibial with severe calcification and ninety percent stenosis.There were no difficulty noted in the balloon during prep.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.A competitor's contrast media and inflation device were used with a 50/50 contrast to saline ratio.The inflation device was successfully used with other devices.There was no resistance/friction while inserting the balloon through the rotating hemostatic valve or the guide catheter.The catheter has never been in an acute bend.The product removed intact (in one piece) from the patient.The device was discarded and is not available for analysis.No other information was provided.

• Brand Name: SABER 2.5MM15CM 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: 11298040
• Report Number: 9616099-2021-04242
• Device Sequence Number: 14711448
• Product Code: LIT
• UDI-Device Identifier: 20705032069066
• UDI-Public: 20705032069066
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2021

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: 09/30/2023
• Device Model Number: 48002515X
• Device Catalogue Number: 48002515X
• Device Lot Number: 82203701
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 02/18/2021; 03/04/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 02/23/2021; 03/08/2021
• 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: ABBOTT INDEFLATOR; VISIPAQUE
• Patient Age: 64 YR