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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO PRECISE PRO RX 9X40; STENT, CAROTID
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CARDINAL HEALTH MEXICO PRECISE PRO RX 9X40; STENT, CAROTID Back to Search Results
Catalog Number PC0940XCE
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2021
Event Type  malfunction  
Manufacturer Narrative
A review of the device history record (dhr) associated with lot 17935174 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be sent in upon 30 days after receipt.
 
Event Description
As reported, it was found that the head-tip of 9 x 40 precise pro rapid exchange (rx) self-expanding stent (ses) delivery system has fallen off after the stent was released, the stent conveying system was withdrawn from the patient.Then the detached head-end was found at the femoral artery puncture unknown sheath.The operator removed the head-tip, the patient was not at risk, and the operation was completed.There was no reported patient injury.The operator performed carotid unknown stent implantation.There were no tortuous and no serious calcification of the femoral artery and carotid artery.The 8f unknown guide catheter was placed into the common carotid artery through puncture unknown sheath.Then placed the 5mm cordis angioguard, and then placed the 9x40mm precise diameter stent to along the protective wire.The operator was trained to the precise pro device.The device was opened in sterile field.The device will be returned for evaluation.
 
Manufacturer Narrative
After further review of additional information received the following sections b5, d9 g3, g6, h2 and h3 have been updated accordingly.Section b5: addendum for additional information has been obtained: the was stored in the cath lab in the cabinet, for one month.The product was stored, handled, and prepped per the instructions for use (ifu).There were no anomalies noted prior to inserting into the patient.There wire was not kinked or damaged in any way prior to insertion into the patient.The stent delivery system did not pass through any acute bends.There was no unusual force used at any time during the procedure.There was no difficulty or resistance noted while crossing the lesion with the stent.There was no resistance met while advancing or withdrawing the device.The target lesion was stenosis of the left internal carotid artery.There was ninety percent stenosis.The device was not used for a chronic total occlusion (cto).There was no difficulty encountered while advancing/tracking the sds towards the lesion.The tip fell off at the y valve, then was removed.The same device was used to complete the procedure.There was no patient injuries, patient is doing fine.The device has been returned for evaluation, but the manufacture report is not yet available.Additional information is pending and will be sent in upon 30 days after receipt.
 
Manufacturer Narrative
As reported, it was found that the head-tip of 9 x 40 precise pro rapid exchange (rx) self-expanding stent (ses) delivery system has fallen off after the stent was released, the stent conveying system was withdrawn from the patient.Then the detached head-end was found at the femoral artery puncture unknown sheath.The operator removed the head-tip, the patient was not at risk, and the operation was completed.There was no reported patient injury.The operator performed carotid unknown stent implantation.The target lesion had ninety percent stenosis of the left internal carotid artery.The device was not used for a chronic total occlusion (cto).There was no tortuous or serious calcification of the femoral artery and carotid artery.The 8f unknown guide catheter was placed into the common carotid artery through puncture unknown sheath.Then placed the 5mm cordis angioguard, and then placed the 9x40mm precise diameter stent along the protective wire.The operator was trained to the precise pro device.The device was opened in sterile field.The product was stored in the cath lab in the cabinet, for one month.The product was stored, handled, and prepped per the instructions (ifu).There were no anomalies noted prior to inserting into the patient.There wire was not kinked or damaged in any way prior to insertion into the patient.The stent delivery system did not pass through any acute bends.There was no unusual force used at any time during the procedure.There was no difficulty or resistance noted while crossing the lesion with the stent.There was no resistance met while advancing or withdrawing the device.There was no difficulty encountered while advancing/tracking the sds towards the lesion.The tip fell off at the y valve, then was removed.The same device was used to complete the procedure.There were no patient injuries reported and the patient is doing fine.The device was returned for analysis.One non-sterile precise pro rx 9x40 was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received opened.Per visual analysis, the stent of the unit was observed deployed but was not received along the unit.The wire lumen was observed separated from the distal tip.The distal tip was not received.Since the distal tip was not received, visual analysis could not determine if the correct amount of adhesive was applied through the entire section between the wire lumen and the tip.Also, the inner shaft coil was observed stretched/elongated and two kinks were observed on the wire lumen, as received.No other anomalies were observed.A product history record (phr) review of lot 17935174 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip - separated - in patient¿ was confirmed as the distal tip was noted to be separated from the wire lumen during device analysis.The inner shaft coil was noted to be stretched/elongated and two kinks were observed on the wire lumen.It is unclear if the damages noted contributed to the separation as the distal tip was not returned.Visual analysis could not determine if the correct amount of adhesive was applied throughout the entire section between the wire lumen and the tip.It was therefore determined by the pet team that the tip separation failure may have been potentially manufacturing related.The physical analysis could not conclusively determine if the correct amount of adhesive was applied through the entire section between the wire lumen and the tip.According to the instructions for use, which is not intended as a mitigation of risk, ¿extract the stent delivery system from the tray.Examine the device for any damage.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.¿ the product analysis suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, a risk assessment has been initiated for further investigation.
 
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Brand Name
PRECISE PRO RX 9X40
Type of Device
STENT, CAROTID
Manufacturer (Section D)
CARDINAL HEALTH MEXICO
av prado sur 150 2d0 piso
ciudad de mexico 11000
MX  11000
MDR Report Key11496245
MDR Text Key245316419
Report Number9616099-2021-04342
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2022
Device Catalogue NumberPC0940XCE
Device Lot Number17935174
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2021
Initial Date Manufacturer Received 02/19/2021
Initial Date FDA Received03/16/2021
Supplement Dates Manufacturer Received03/17/2021
04/27/2021
Supplement Dates FDA Received04/12/2021
05/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
5MM CORDIS ANGIOGUARD; UNK 8F GUIDE CATHETER
Patient Age49 YR
Patient Weight68
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