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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION SABER 2.5MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CORDIS CORPORATION SABER 2.5MM30CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 48002530X
Device Problems Partial Blockage (1065); Material Frayed (1262); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, a non-cordis. 018 wire became stuck inside the lumen of a saber 2. 5mm 30cm 150cm balloon catheter. Also reported, it appeared the coating inside the catheter was peeled off. The wire and balloon catheter were removed intact from the patient. There was no reported patient injury. The device was stored per the instructions for use (ifu). There was no difficulty removing the product from the packaging. There were no anomalies noted to the device after removed from the packaging. The device was prepped per the ifu without any difficulty noted. The inner stylet was removed from the balloon catheter. A 6f non-cordis sheath was inserted into the femoral artery in attempt to treat the anterior tibial (at). The target site had a 100% stenosis (chronic total occlusion) with mild calcification. After the balloon crossed the lesion and after dilation, the wire got stuck post dilation. There was no resistance/friction noted while advancing the catheter through the sheath. There was no unusual force used during the procedure. Another unknown balloon catheter and wire was used to complete the case. The device will be returned for evaluation.
 
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Brand NameSABER 2.5MM30CM 150
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key12689734
MDR Text Key278150616
Report Number9616099-2021-05001
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K971010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48002530X
Device Catalogue Number48002530X
Device Lot Number82226780
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/17/2021
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: 10/25/2021 Patient Sequence Number: 1
Treatment
SABER BALLOON; UNKNOWN WIRE
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