MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM4CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48006004X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot (82189653) presented no issues during the manufacturing process that can be related to the reported event.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon of a 6mm x 4mm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was in a heavily calcified superficial femoral artery (sfa) and then popped during inflation.Therefore, another 6mm x 4mm saber pta balloon was used to complete the procedure.There was no reported patient injury.The user was trained with the device.The device was opened in a sterile field.The vessel level of calcification is severe.The vessel level of angulation and tortuosity is mild.The device was prepped per the instructions for use (ifu).The device was prep normal.The contrast to saline ratio was 30/70.The same indeflator was used successfully with other devices.The balloon inflated normally.The maximum inflation pressure was 16-atmospheres pressure (atm).The catheter was not torqued against resistance.There were no kink/bent noted after device was removed from patient.There was no unusual force used at any time during the procedure.The device was removed intact (in one piece) from the patient.The device will be returned for evaluation.
Additional Manufacturer Narrative
The balloon of a 6mm x 4mm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter was in a heavily calcified superficial femoral artery (sfa) and then popped during inflation.The maximum inflation pressure was 16-atmospheres pressure (atm).Therefore, another 6mm x 4mm saber pta balloon was used to complete the procedure.There was no reported patient injury.The user was trained with the device.The device was opened in a sterile field.The vessel level of calcification is severe.The vessel level of angulation and tortuosity is mild.The device was prepped per the instructions for use (ifu).The device was prep normal.The contrast to saline ratio was 30/70.The same indeflator was used successfully with other devices.The balloon inflated normally.The catheter was not torqued against resistance.There were no kink/bent noted after device was removed from patient.There was no unusual force used at any time during the procedure.The device was removed intact (in one piece) from the patient.The product was returned for analysis.A non-sterile saber 6mm x 4cm x 150 balloon catheter was received for analysis coiled inside a plastic bag.Per visual analysis, dried blood residues were observed on the balloon of the unit.The balloon had been previously inflated.No other physical characteristics could be observed at the naked eye.Functional test was intended to be performed on the unit.A syringe filled with water was attached to the inflation lumen and pressure was applied.However, a leakage was observed due to an approximately 2cm rupture observed on the proximal section of the balloon.Per microscopic analysis, sem analysis was performed to the received balloon unit to identify the possible root cause of the rupture condition on the balloon with the following results: sem results showed that the external surface of the balloon showed evidence of abrasions, scratched marks, and peel-off material near the rupture.This type of damage is commonly caused during the interaction of the balloon material with a sharp object or mechanical damage.Likely, the same factors that caused the observed abrasions, scratched marks, and peel-off material on the balloon external surface probably lead to the ruptured condition found on the received balloon.The internal surface of the balloon did not present evidence of damages on the surrounding areas of the rupture.Neither evidence of damages was found on the analyzed proximal marker band.It appears the balloon material near the rupture was torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.No other anomalies were found during the analysis.No other anomalies were found during the sem analysis.A product history record (phr) review of lot: 82189653 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¿ was confirmed via device analysis.A leakage was confirmed through analysis of the returned device due to an approximate 2cm rupture noted on the balloon surface.The outer surface of the balloon presented evidence of abrasions, scratch marks, and peeled-off material.The vessel was described as severely calcified, it is likely these characteristics may have contributed to the reported event as evidenced by device analysis.The balloon material near the rupture, appears to have been torn either due to the interaction of the balloon with calcified spicules located on the lesion or with a sharp object from the outside of the balloon.According to the warnings in the safety information in the instructions for use ¿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.

• Brand Name: SABER 6MM4CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10546979
• Report Number: 9616099-2020-03910
• Device Sequence Number: 3073509
• Product Code: LIT
• UDI-Device Identifier: 20705032068175
• UDI-Public: 20705032068175
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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: 02/28/2023
• Device Model Number: 48006004X
• Device Catalogue Number: 48006004X
• Device Lot Number: 82189653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 09/29/2020
• 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: SABER PTA BALLOON (6MM X 4MM); SABER PTA BALLOON (6MM X 4MM)