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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 2MM2CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS DE MEXICO SABER 2MM2CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 48002002S
Device Problems Material Frayed (1262); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/27/2017
Event Type  malfunction  
Manufacturer Narrative
After further review of additional information received the sections have been updated accordingly. As reported, a 2x20mm 90cm saber balloon catheter (bc) was unable to be inflated. A slit on the balloon was confirmed. It is unknown how the procedure completed however, the procedure was finished successfully. There was no reported patient injury. The patient¿s information was unknown. The target lesion was unknown. The patient¿s vessel level of tortuosity and calcification was unknown. The rate of stenosis was unknown. The device was stored and handled per the instructions for use (ifu). There were no anomalies noted to the device when it was taken out of the packaging. There were no difficulties removing the product from the packaging, stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover. The product was inspected prior to use and appear to be normal. The device was prepped per the ifu and prepped normally (i. E. Maintain negative pressure). There were no kinks or other damages noted prior to inserting the product into the patient. The product removed intact (in one piece) from the patient. Additional procedural details were requested but are unknown. One non-sterile unit of saber 2mm2cm 90 was received coiled inside a plastic bag. The balloon was received deflated and appears to have been inflated. Per visual analysis, no frayed/split/torn conditions, nor other damages were found on the balloon. No other anomalies were observed in the returned unit. Leak test was performed, and a leakage was observed in the hub during the test. Microscopic analysis was performed, the saber catheter was inspected under vision system and no damages were observed on balloon, however, a cracked condition was observed on the unit¿s hub. The unit was sent to scanning electron microscopy (sem) analysis to identify the root cause of the leak on the hub. Sem results showed that the crack passed through the thickness of the hub. Transversal view of the fractured section of the hub showed a fracture pattern that presents evidence of plastic deformations along the fractured surfaces of the hub, commonly found on tensile fractured surfaces. No other anomalies were found during sem analysis. A device history record (dhr) review of lot 17526104 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon frayed/split/torn in patient¿ was not confirmed through analysis of the returned device since there were no damages noted to the balloon. However, a leakage was found on the saber balloon¿s hub due to cracked condition found. The exact cause of this reported failure as well the cracked condition could not be conclusively determined during analysis. Based on the limited information available for review, procedural/handling factors likely contributed to the cracked hub and subsequent leakage noted during analysis as evidenced by plastic deformations commonly found on tensile fractured surfaces. According to the ifu, 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. Flush all devices entering the vascular system with sterile heparinized saline or similar isotonic solution. Prior to use, ensure all devices have been flushed and air is removed from the system according to standard medical practice. Failure to do so could result in air entering the vascular 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.
 
Manufacturer Narrative
A review of the manufacturing documentation associated with this lot # 17526104 presented no issues during the manufacturing process that can be related to the reported event. This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt.
 
Event Description
As reported, a saber 2mmx2cm 90 balloon was unable to be inflated. A slit on the balloon was confirmed. There was no reported patient injury. The patient¿s information was unknown. The target lesion was unknown. The patient¿s vessel level of tortuosity and calcification was unknown. The rate of stenosis was unknown. The device was stored and handled per the instructions for use (ifu). There were no anomalies noted to the device when it was taken out of the packaging. There were no difficulties removing the product from the packaging, stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover. The product was inspected prior to use and appear to be normal. The device was prepped per the ifu and prepped normally (i. E. Maintain negative pressure). There were no kinks or other damages noted prior to inserting the product into the patient. It is unknown how the procedure completed however, the procedure was finished successfully. The product removed intact (in one piece) from the patient. The device will be returned for analysis. Additional procedural details were requested but are unknown.
 
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Brand NameSABER 2MM2CM 90
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX 32575
Manufacturer (Section G)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX 32575
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6967788
MDR Text Key252183002
Report Number9616099-2017-01518
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Catalogue Number48002002S
Device Lot Number17526104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2016
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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