MAUDE Adverse Event Report: CORDIS CORPORATION SABER 3MM4CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48003004X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a 3mm x 4cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured at around 12 atmospheres (atm) for the second time.The procedure was completed using a same sized non-cordis pta balloon catheter.There was no reported patient injury.This was to treat severe stenosis with strong calcification of the right popliteal artery using a 4.5f 55cm non-cordis sheath for an ipsilateral femoral approach.Two non-cordis guidewires were used in combination to cross the lesion.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 82173084 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 strong calcification and with severe stenosis likely contributed to the reported event as calcification is known to damage balloon material.The balloon material may have encountered calcification during delivery or balloon expansion.However, 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 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.
Event or Problem Description
As reported, a 3mm x 4cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter ruptured at around 12 atmospheres (atm) for the second time.The procedure was completed using a same sized non-cordis pta balloon catheter.There was no reported patient injury.This was to treat severe stenosis with strong calcification of the right popliteal artery using a 4.5f 55cm non-cordis sheath for an ipsilateral femoral approach.Two non-cordis guidewires were used in combination to cross the lesion.The device will not be returned for evaluation as it was already discarded.

• Brand Name: SABER 3MM4CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11893335
• Report Number: 9616099-2021-04583
• Device Sequence Number: 16994353
• Product Code: LIT
• UDI-Device Identifier: 20705032069097
• UDI-Public: 20705032069097
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2021

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: 06/30/2022
• Device Model Number: 48003004X
• Device Catalogue Number: 48003004X
• Device Lot Number: 82173084
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1