MAUDE Adverse Event Report: CORDIS CASHEL SABER 3MM6CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 48003006S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17598461) presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the tip of the saber pta (3mm6cm 90) dilatation catheter has disassociated before introduction into the patient's artery. There was no reported patient injury. The device will be return for analysis. Initially, the patient was hospitalized for arterial angioplasty transluminal of left leg and amputation of the third (3rd) toe left foot due to kidney failure chronic.

Manufacturer Narrative

As reported, the tip of the 3x60mm 90cm saber percutaneous transluminal angioplasty (pta) catheter dilatation catheter was disassociated before introduction into the patient's artery. There was no reported patient injury. Initially, the patient was hospitalized for arterial angioplasty transluminal of left leg and amputation of the third (3rd) toe left foot due to chronic kidney failure. One non-sterile saber 3mm6cm 90 was received coiled inside a plastic bag. The balloon was already inflated. Distal tip was received separated. No other anomalies were noted in the returned device. The unit was sent to scanning electron microscope (sem) analysis in order to analyze the potential cause of the separation. Sem results showed that the distal and proximal sections of the separated tip presented evidence of elongations. The elongations observed suggest that the tip¿s separated areas were induced to stretching/pulling events that exceeded the tip¿s material yield strength prior to the separation. No other issues were noted during sem analysis. A device history record (dhr) review of lot 17598461 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿distal tip separated¿ was confirmed through analysis of the returned device. However, the exact cause of the reported failure could not be conclusively determined during analysis. Based on the limited information provided, procedural/handling may have contributed to the reported event as evidenced by the presence of elongations at the separated area during sem analysis. According to the instructions for use (ifu), which is not intended as a mitigation, ¿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 review nor the product analysis suggests that the event experienced by the customer could be related to the design or manufacturing process of the product. Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SABER 3MM6CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, co. tipperary; EI
• MDR Report Key: 7492280
• Report Number: 9616099-2018-02117
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 48003006S
• Device Lot Number: 17598461
• Was Device Available for Evaluation?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Age: 72 YR