MAUDE Adverse Event Report: CORDIS CASHEL SABER 6MM2CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48006002X

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: as reported, the 6 x 20 mm 150 cm saber balloon was damaged.The issue was further clarified as the device was kinked/bent, fractured at the tip.There was no reported patient injury.The malfunction was noticed during prep.The device was not prepped normally (i.E.Maintain negative pressure).There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.The device was not used inside the patient.The product was not returned for analysis.A device history record (dhr) review of lot 17588608 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip cracked during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause of the fractured tip could not be determined.Based on the limited information available for review, handling factors may have contributed to the reported event.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.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported, the saber (6 mm 2 cm 150) balloon was damaged.There was no reported patient injury.The product will not be returned.The device was kinked and bent, fractured at the tip.The malfunction was noticed during prep.The device was not prepped normally (i.E.Maintain negative pressure).There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.The device was not used inside the patient.

Manufacturer Narrative

As reported, the 6x20mm 150cm saber balloon catheter (bc) was damaged.The device was kinked and bent, fractured at the tip.The device was not used inside the patient.There was no reported patient injury.The malfunction was noticed during prep.The device was not prepped normally (i.E.Maintain negative pressure).There was no difficulty removing the product from the hoop, the protective balloon cover, or the stylet or any of the sterile packaging components.Two pictures of a saber 6mm2cm 150 unit were received.In the first picture, the original packaging of the involved product can be observed.In the second picture, a pleat condition on the balloon at the distal tip section could be observed as well as blood residues on balloon.However, the cause of the damage observed on the unit cannot be conclusively determined based on the picture information provided.A device history record (dhr) review of lot 17588608 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip cracked during prep¿ was not confirmed through analysis of the received pictures.However, a pleat condition was observed on the balloon.The cause of the damage observed could not be conclusively determined during picture analysis.Based on the limited information available for review, handling factors most likely contributed to the damages reported.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.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.¿ neither the dhr review nor the picture analysis suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: SABER 6MM2CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel; co. tipperary ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7546474
• MDR Text Key: 109753045
• Report Number: 9616099-2018-02158
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 48006002X
• Device Catalogue Number: 48006002X
• Device Lot Number: 17588608
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2016
• 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