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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CASHEL SABER RX25MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CASHEL SABER RX25MM4CM155 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 51002504L
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/09/2017
Event Type  malfunction  
Manufacturer Narrative
It was reported that the saber rx balloon catheter tip was separated in two pieces before it was put in the patient. The procedure was completed with a non cordis balloon. There was no patient injury. The saber rx balloon catheter was placed over the guidewire and before the balloon entered the sheath, the tip of the balloon catheter was broken in two parts. The product was inspected prior to use and appear to be normal. The product prepped properly according to the instruction for use (ifu) with no problems noted during prepping. One non-sterile saber rx 2. 5mm4cm155cm was received for analysis coiled inside a plastic bag. Per visual analysis, the tip of the balloon catheter was observed separated /damaged (the separated piece was not returned for analysis). No other anomalies observed. The separation of the catheter distal tip was observed under vision system and tip presented elongations and frayed edges. These characteristics presented evidence of application of a tension/force that induced the separation. No other issues were noted. A device history record (dhr) review of lot 17334360 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 separation could not be conclusively determined during analysis. Based on the limited information available for review, handling factors may have contributed to the issue reported as evidenced by presence of elongations and frayed edges at the separation site. The ifu has been reviewed, and it states that separation of a device component is a potential complication. According to the instructions for use ¿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; therefore, no corrective/preventive action will be taken at this time.
 
Event Description
It was reported that the saber rx balloon catheter tip was separated in two pieces before it was put in the patient. The procedure was completed with a non cordis balloon. There was no patient injury. The saber rx balloon catheter was placed over the guidewire and before the balloon entered the sheath, the tip of the balloon catheter was broken in two parts. The product was inspected prior to use and appear to be normal. The product prepped properly according to the instruction for use (ifu) with no problems noted during prepping.
 
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Brand NameSABER RX25MM4CM155
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CASHEL
cahir road
cashel, tp
EI
Manufacturer (Section G)
CORDIS CASHEL
cahir road
cashel, tp
EI
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6610855
MDR Text Key76719980
Report Number9616099-2017-01143
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Model Number51002504L
Device Catalogue Number51002504L
Device Lot Number17334360
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/10/2017
Event Location No Information
Date Manufacturer Received05/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/15/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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