MAUDE Adverse Event Report: CORDIS CASHEL SABER RX5MM15CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51005015L

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.  the product was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, during an interventional endovascular procedure, a 155 cm.Saber 5 mm.X 15 cm.Balloon catheter (bc) was used to post-dilate an unknown stent.However, the pressure did not rise more than eight atmospheres (8 atm.) and started to decrease.The physician assumed that the balloon ruptured.After removal of the product from the patient however, a leakage was confirmed from the middle part of its shaft.Therefore it was replaced with a new balloon catheter.The procedure finished successfully.There was no reported patient injury.The product was clinically used and it will be returned for analysis.The target lesion was the left superficial femoral artery (lsfa).The lesion was a one hundred percent (100%) stenosis/chronic total occlusion (cto).No other target lesion characteristic information was provided.A contralateral approach was made from the right groin with a non-cordis guiding sheath.The occluded superficial femoral artery was crossed with some (unknown) guidewires, and an unknown balloon (3 mm.) was inflated in the lesion for pre-dilatation.Then an unknown stent was deployed.Additional information received indicated that it was unknown if any of the guidewires used were cordis products or if the stent that was implanted was a cordis product.There were no any reported product issues with any of the additional products used-guidewires or the previously implanted stent.Contrast leakage was observed during the inflation from the shaft.No additional target lesion characteristic information was available.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.There was no reported difficulty removing the product from the hoop.There was no reported difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device prepped normally (i.E.Maintained negative pressure).The product was removed intact (in one piece) from the patient.Additional information was requested but was reported to be unknown.No additional information is available.

Manufacturer Narrative

As reported, during an interventional endovascular procedure, a 155 cm.Saber 5 mm.X 15 cm.Balloon catheter (bc) was used to post-dilate an unknown stent.However, the pressure did not rise more than eight atmospheres (8 atm.) and started to decrease.The physician assumed that the balloon ruptured.After removal of the product from the patient however, a leakage was confirmed from the middle part of its shaft.Therefore, it was replaced with a new balloon catheter.The procedure finished successfully.There was no reported patient injury.The target lesion was the left superficial femoral artery (lsfa).The lesion was a one hundred percent (100%) stenosis/chronic total occlusion (cto).No other target lesion characteristic information was provided.A contralateral approach was made from the right groin with a non-cordis guiding sheath.The occluded superficial femoral artery was crossed with some (unknown) guidewires, and an unknown balloon (3 mm.) was inflated in the lesion for pre-dilatation.Then an unknown stent was deployed.Additional information received indicated that it was unknown if any of the guidewires used were cordis products or if the stent that was implanted was a cordis product.There were no any reported product issues with any of the additional products used-guidewires or the previously implanted stent.Contrast leakage was observed during the inflation from the shaft.No additional target lesion characteristic information was available.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.There was no reported difficulty removing the product from the hoop.There was no reported difficulty removing the protective balloon cover, stylet, or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product into the patient.The device prepped normally (i.E.Maintained negative pressure).The product was removed intact (in one piece) from the patient.Additional information was requested but was reported to be unknown.No additional information is available. one non-sterile unit of saber rx5mm15cm155 was received coiled inside a plastic.The balloon was received deflated and appeared to have been inflated.No other anomalies were observed in the returned device.A leak test was performed, and a leakage was observed through catheter body at 116 cm from distal end.Unit was sent to sem analysis to find the potential cause of the leak and results showed that the external surface presented evidence of scratches and abrasion marks near to the split observed on the outer body.These characteristics are likely the result of the interaction of the device with a sharp object that also caused the split on the device body.No other anomalies were found during the analysis.A device history record (dhr) review of lot 17565913 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿body/shaft- leakage - in-patient¿ was confirmed through analysis of the returned device.The exact cause of the leak found could not be conclusively determined during analysis.However, based on the limited information available for review, procedural/handling factors may have led to the split found on the device as evidenced by the scratches and abrasion marks at the area of the split/leakage noted during sem 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 ensure that its size and shape are suitable for the specific procedure for which it is to be used.Carefully advance the catheter to the selected stenosis.Caution: if strong resistance is met during advancement or withdrawal of the catheter, discontinue movement and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, withdraw the entire system.¿ 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 RX5MM15CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel co., tiperrary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel co., tiperrary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6684663
• MDR Text Key: 79036735
• Report Number: 9616099-2017-01207
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 51005015L
• Device Lot Number: 17565913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/13/2017
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/03/2017
• Supplement Dates Manufacturer Received: 07/15/2017
• Supplement Dates FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1