MAUDE Adverse Event Report: CORDIS CASHEL SABER RX6MM2CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 51006002L

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 Description

During use, it was reported that the saber balloon catheter shaft was cracked after it was noted that pressure could not be applied.There was no patient injury.The saber balloon was replaced with a new saber balloon (different size) and the procedure completed successfully.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The product was clinically used and will be returned for analysis.

Manufacturer Narrative

Additional information was received and section was updated.During use, it was reported that the saber balloon catheter shaft was cracked after it was noted that pressure could not be applied.There was no patient injury.The saber balloon was replaced with a new saber balloon (different size) and the procedure completed successfully.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The device was prep normally.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.There was no damages noted after the device was removed from the patient.The device did not kinked anytime during the procedure.The device was prepped according to the instruction for use (ifu).There was no excess force used during prep.There was no damages noted to the device packaging.There was no difficulty removing the device from the packaging.There was no difficulty tracking towards the lesion.The device is available for analysis.No other information was provided.

Manufacturer Narrative

This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

During use, it was reported that the saber balloon catheter shaft was cracked after it was noted that pressure could not be applied.There was no patient injury.The saber balloon was replaced with a new saber balloon (different size) and the procedure completed successfully.The target lesion, vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.A non-sterile saber rx6mm2cm155 was received coiled inside of a clear plastic bag.A first visual inspection without any optical magnifying device was performed and no damages or anomalies were observed at the balloon or at the rest of the balloon catheter.A functional test was performed.The inflator/deflator device was attached to the inflation lumen.Balloon inflation test was done applying pressure with the inflator/deflator device to reach the nominal pressure of 8 atmospheres (atm).A leakage was observed on the body/shaft at 59 cm from the hub.The part was placed under microscope and scratches were observed where the leakage was located.Sem results showed that the rupture passed through thickness of the saber body.It was noticed that the rupture presented as rips and elongations.Per the available evidence, it¿s very likely that the rupture and ripped conditions found on the saber body are results of the interaction of the saber body surface with an unknown object that caused such damages.No other issues were observed during the sem analysis.A device history record (dhr) review of lot 17449265 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft - cracked¿ was not confirmed through analysis of the returned device.However, a leakage was observed on body/shaft at 59 cm from the hub which can appear as a crack in the body of the device to the customer.The exact cause of the leakage found at the catheter could not be conclusively determined during the analysis.Based on the limited information available for review, procedural factors and handling process may have contributed to the issue reported as evidenced by the scratches, rips and elongations noted at the leakage site during analysis.According to the instructions for use, which is not intended as a mitigation, ¿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.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

This regulatory supplemental report was created an error' there is no additional information.

Manufacturer Narrative

Additional information was received to provide the complaint conclusion for the additional information that was received.There was no change to the method, result or conclusion codes.During use, it was reported that the 6x20mm 155cm saber balloon catheter shaft was cracked after it was noted that pressure could not be applied.The saber balloon was replaced with a new saber balloon (different size) and the procedure completed successfully.There was no patient injury.The target lesion, vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The device was prep normally.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.There was no damages noted after the device was removed from the patient.The device did not kinked anytime during the procedure.The device was prepped according to the instruction for use (ifu).There was no excess force used during prep.There was no damages noted to the device packaging.There was no difficulty removing the device from the packaging.There was no difficulty tracking towards the lesion.No other information was provided.A non-sterile saber rx6mm2cm155 was received coiled inside of a clear plastic bag.A first visual inspection without any optical magnifying device was performed and no damages or anomalies were observed at the balloon or at the rest of the balloon catheter.A functional test was performed.The inflator/deflator device was attached to the inflation lumen.Balloon inflation test was done applying pressure with the inflator/deflator device to reach the nominal pressure of 8 atmospheres (atm).A leakage was observed on the body/shaft at 59 cm from the hub.The part was placed under microscope and scratches were observed where the leakage was located.Sem results showed that the rupture passed through thickness of the saber body.It was noticed that the rupture presented as rips and elongations.Per the available evidence, it¿s very likely that the rupture and ripped conditions found on the saber body are results of the interaction of the saber body surface with an unknown object that caused such damages.No other issues were observed during the sem analysis.A device history record (dhr) review of lot 17449265 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft - cracked¿ was not confirmed through analysis of the returned device.However, a leakage was observed on body/shaft at 59 cm from the hub which can appear as a crack in the body of the device to the customer.The exact cause of the leakage found at the catheter could not be conclusively determined during the analysis.Based on the limited information available for review, procedural factors and handling process may have contributed to the issue reported as evidenced by the scratches, rips and elongations noted at the leakage site during analysis.According to the instructions for use, which is not intended as a mitigation, ¿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.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SABER RX6MM2CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary ; EI
• MDR Report Key: 7299511
• MDR Text Key: 101255732
• Report Number: 9616099-2018-01951
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 51006002L
• Device Catalogue Number: 51006002L
• Device Lot Number: 17449265
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/02/2018
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1