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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS DE MEXICO SLALOM PTA .018 HP 40 5X4 CATHETER PTA CATHETER

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CORDIS DE MEXICO SLALOM PTA .018 HP 40 5X4 CATHETER PTA CATHETER Back to Search Results
Model Number N/A
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Catheter (3038); Tip (3123)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/25/2017
Event Type  Injury  
Manufacturer Narrative

(b)(6). This device is available for analysis but has not yet been received.   a device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.   additional information is pending and will be submitted within 30 days upon receipt.

 
Event Description

Following a percutaneous transluminal angioplasty (pta) shunt case with a. 018 hp 40 5x4 slalom thrill pta catheter, when it was removed, the balloon stuck with the sheath introducer and 1 cm of the distal tip separated inside the patient. Then the fragment was removed by pull-through.  the fragment of the balloon was with the concomitant guidewire, so another site was punctured to catch it with a goose neck snare catheter. However it failed to remove the fragment. So an angio catheter pushed the fragment and the sheath out together. When the goose neck snare catheter and the angio catheter were removed, they perforated the artery, and the patient¿s arm swelled and turned red. By using a small-size slalom thrill, hemostasis of the perforation was done and the patient is well so far.  it was unknown how the procedure completed but the procedure was finished successfully. There was no reported patient injury. The product will be returned for analysis.   the target lesion was unknown. The patient¿s vessel level of tortuousness and calcification was unknown. The rate of stenosis was unknown.   the balloon had been inflated in the lesion and deflated.  there was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and no difficulty removing the stylet or any of the sterile packaging components.   there were no kinks or other damages noted prior to inserting the product the product into the patient.   the device prepped normally.   additional procedural details were requested but are unknown.  the maker of the concomitant guidewire is unknown.

 
Manufacturer Narrative

The device was returned and was updated accordingly.    the completed engineering report will be submitted within 30 days upon receipt.

 
Manufacturer Narrative

Following a percutaneous transluminal angioplasty (pta) shunt case with a. 018 hp 40 5x4 slalom thrill pta catheter, when it was removed, the balloon got stuck with the sheath introducer and 1 cm of the distal tip separated inside the patient. The fragment was removed by pull-through. The fragment of the balloon tip was with the concomitant guidewire, so another site was punctured to catch it with a goose neck snare catheter. However it failed to remove the fragment. So an angiography catheter was pushed to the fragment and the sheath together. When the goose neck snare catheter and the catheter were removed. However, they perforated the artery, and the patient¿s arm swelled and turned red. By using a small-size slalom thrill, hemostasis of the perforation was done and the patient is well so far. It was unknown how the procedure completed but the procedure was finished successfully. There was no reported patient injury. The target lesion was unknown. The patient¿s vessel level of tortuousness and calcification was unknown. The rate of stenosis was unknown. The balloon had been inflated in the lesion and deflated. There was no difficulty removing the product from the hoop, no difficulty removing the protective balloon cover and no difficulty removing the stylet or any of the sterile packaging components. There were no kinks or other damages noted prior to inserting the product the product into the patient. The device prepped normally. Additional procedural details were requested but are unknown.   one non sterile slalom pta. 018 hp 40 5x4 was received inside a plastic bag. Per visual analysis, it was noticed that the balloon presented a rupture/separation at balloon¿s middle section (the balloon distal section was found ruptured/separated). Additionally the inner body was found also separated. No other issues were found. The unit was sent to sem analysis and results showed that the external surface of balloon presented evidence of abrasions and scratch marks near the balloon rupture. It¿s very likely that the same factors that caused the scratch marks on the balloon¿s outer surface could have also contributed to the rupture found on the received balloon. The internal surface did not presented any evidence of damages. The inner body separated section presented evidence of elongations at the surrounding areas of the separation. The elongations observed suggests that the device was induced to stretching/pulling events that exceeded the material¿s yield strength prior to the separation. No other issues were noted during sem analysis. No other anomalies were found during the analysis. Dimensional analysis for od proximal seal was performed and was found within specification. A device history record (dhr) review of lot 17597351 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.   the reported ¿pta/ptca system withdrawal difficulty¿ and ¿distal tip separated - in-patient¿ were confirmed through analysis of the returned device. The exact cause of the withdrawal difficulty and separation reported could not be determined during analysis. Based on the limited information available for review, vessel characteristics (although unknown) and procedural/handling factors may have contributed to the burst, withdrawal difficulty and separation reported as evidenced by the scratch marks on the balloon¿s surface and the elongation noted at the separated areas during sem analysis. According to the instructions for use, which is not intended as a mitigation, ¿prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used. The catheter system should be used only by physicians trained in the performance of arteriography and who have received appropriate training in percutaneous transluminal angioplasty. Note: gentle counterclockwise rotation of the balloon may ease withdrawal from the sheath or from the percutaneous entry site. If the balloon cannot be withdrawn through the sheath or guiding catheter, check if the balloon is fully deflated. If not, withdraw the catheter and sheath as one unit. If strong resistance is met during advancement or withdrawal of the balloon catheter, discontinue movement and determine the cause of resistance before proceeding. If the cause of resistance cannot be determined, withdraw the entire 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.

 
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Brand NameSLALOM PTA .018 HP 40 5X4 CATHETER
Type of DevicePTA CATHETER
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 Key6574999
MDR Text Key75439525
Report Number9616099-2017-01104
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK003159
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 07/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/18/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/19/2019
Device MODEL NumberN/A
Device Catalogue Number4395040T
Device LOT Number17597351
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date04/25/2017
Event Location No Information
Date Manufacturer Received07/11/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/29/2016
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: 05/18/2017 Patient Sequence Number: 1
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