MAUDE Adverse Event Report: CORDIS CASHEL SABER RX3MM15CM155; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 51003015L

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned for analysis as it was discarded.A review of the manufacturing documentation associated with this lot 17335227 presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

A saber rx 3 mm 15 cm 155 was inserted, but there was difficulty crossing the calcification.Then the distal tip got frayed.Therefore it was replaced with a new balloon catheter.The procedure completed successfully.There was no reported patient injury.The product was clinically used and it has been discarded in the hospital due to possible infectious disease and will not be returned for analysis.The target lesion was from the superficial femoral artery to the bk.The patient¿s information, patient¿s vessel level of tortuousness, vessel was calcified and rate of stenosis was unknown.Additional information has been requested.

Manufacturer Narrative

A 3x150mm 155cm saber rx percutaneous transluminal angioplasty (pta) catheter was inserted, but there was difficulty crossing the calcification.Then, the distal tip got frayed.Therefore, it was replaced with a new balloon catheter.The procedure completed successfully.There was no reported patient injury.The target lesion was from the superficial femoral artery to the below the knee (bk).The patient¿s information, patient¿s vessel level of tortuousness, vessel was calcified and rate of stenosis was unknown.Multiple attempts were made without success to obtain additional information.The device was not returned for analysis because the patient had an infectious disease.A device history record (dhr) review of lot 17335227 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip frayed/split/torn¿ could not confirmed as the device was not returned for analysis.The exact cause of the failure experienced could not be determined.Based on the limited information available for review, vessel characteristics (crossing difficulty the lesion) and handling factors may have contributed to the reported frayed tip.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

A saber rx 3 mm 15 cm 155 was inserted, but there was difficulty crossing the calcification.Then the distal tip got frayed.Therefore it was replaced with a new balloon catheter.The procedure completed successfully.There was no reported patient injury.The product was clinically used and it has been discarded in the hospital due to possible infectious disease and will not be returned for analysis.The target lesion was from the superficial femoral artery to the bk.The patient¿s information, patient¿s vessel level of tortuousness, vessel was calcified and rate of stenosis was unknown.Multiple attempts were made without success to obtain additional information.

• Brand Name: SABER RX3MM15CM155
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary ; EI
• MDR Report Key: 7173121
• MDR Text Key: 97723688
• Report Number: 9616099-2018-01766
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 51003015L
• Device Lot Number: 17335227
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention