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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 3MM30CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS DE MEXICO SABER 3MM30CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number 48003030S
Device Problem Detachment Of Device Component (1104)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 09/08/2017
Event Type  Injury  
Manufacturer Narrative
As reported, a 3 x 300 mm 90 cm saber balloon separated into two pieces during the procedure. The separated segment was retrieved with a snare. Another balloon was used to complete the procedure. The procedure was completed successfully without patient injury, however there was prolongation of the operating time. The vessel characteristics were unknown. The device was stored and handled per the instructions for use (ifu). There were no difficulties removing the product from the packaging, the 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 appeared to be normal. The device was prepped properly according to 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. Additional procedural details were requested but are unknown. The device was not returned for analysis. A device history record (dhr) review of lot 17556233 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The reported ¿balloon separated in patient¿ could not be confirmed as the device was not returned for analysis. The exact cause of the separation could not be determined. Based on the limited information available for review, vessel characteristics (although unknown) and handling factors may have contributed to the reported event as calcification/resistant lesions may cause damage to a balloon and handling of the balloon catheter after damage can lead to a separation. According to the instructions for use, which is not intended as a mitigation, ¿when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of resistance before proceeding. If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected. 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. (b)(4).
 
Event Description
As reported, a saber 3 mm x 30 cm 90 balloon separated into two pieces during the procedure. The device was stored and handled per the instructions for use (ifu). There were no difficulties removing the product from the packaging, the 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 appeared to be normal. The device was prepped properly according to 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 separated segment was retrieved with a snare. Another balloon was used to complete the procedure. The procedure was completed successfully without patient injury, however there was prolongation of the operating time. Additional procedural details were requested but are unknown.
 
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Brand NameSABER 3MM30CM 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 Key7057924
MDR Text Key92881737
Report Number9616099-2017-01614
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 11/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue Number48003030S
Device Lot Number17556233
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/24/2017 Patient Sequence Number: 1
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