MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO LONG GEN / PRO 29 X 90 BIL 135; CATHETER, BILIARY, DIAGNOSTIC

Model Number	PG2990BPX
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, when the balloon of a.035¿ 29mm x 30mm x 135cm palmaz genesis transhepatic biliary stent on opta pro percutaneous transluminal angioplasty (pta) balloon expandable stent delivery system (sds) came out of the 7f non-cordis sheath, there was no stent on it.The physician searched all vessels from head to toe on fluro but could not find a dislodged stent.He also checked if it was in the ¿shuttle sheath¿ but found nothing.There was no reported patient injury.The balloon was removed to inspect it to see if the stent was on it.Afterwards, the physician used the same balloon for angioplasty the lesion.The lesion was the right common carotid which was calcified, tortuous, at a bifurcate and in an acute angle with ninety-five percent stenosis.The device was stored and handled per the instructions for use.There was no difficulty experienced in prepping the device.The access site was femoral, and a contralateral approach used.A competitor¿s sheath and an aquatrack guidewire were used.The device was stored as per labeling and was opened in a sterile field.The device will be returned for evaluation.No other information was provided.
Additional Manufacturer Narrative
When the balloon of a.035¿ 29mm x 30mm x 135cm palmaz genesis transhepatic biliary stent on opta pro percutaneous transluminal angioplasty (pta) balloon expandable stent delivery system (sds) came out of the 7f non-cordis sheath, there was no stent on it.The physician searched all vessels from head to toe with fluoro but could not find a dislodged stent.He also checked if it was in the ¿shuttle sheath¿ but found nothing.There was no reported patient injury.The balloon was removed to see if the stent was on it.Afterwards, the physician used the same balloon to angioplasty the lesion.The lesion was the right common carotid which was calcified, tortuous, at a bifurcate and in an acute angle with ninety-five percent stenosis.The device was stored and handled per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The access site was femoral and a contralateral approach used.A non-cordis sheath and an aquatrack guidewire were used.The device was stored as per labeling and was opened in a sterile field.No other information was provided.The device was returned for analysis.Per visual analysis, the balloon was received deflated observing stent struts marks on it.The stent was not received for analysis.No damages or anomalies were observed during visual analysis.Per microscopic analysis, the balloon was inspected using a vision system to obtain a magnified image and stent struts marks were observed on the balloon surface.This indicates that the device complied with the stent crimp process.A product history record (phr) review of lot: 82185924 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent - dislodged¿ could not be confirmed as the stent was not returned for analysis and the stent struts marks were observed on the balloon surface indicating that the device complied with the stent crimp process.The exact cause of the reported event could not be conclusively determined during the analysis.Procedural/handling factors, such as operator technique, or vessel characteristics such as the tortuosity and calcification described, may have contributed to the reported event.According to the ifu, which is not intended as a mitigation of risk, the device was used off label in the right common carotid artery and at a bifurcate.¿the cordis palmaz genesis® peripheral stent on opta® pro.035" delivery system is intended for use in the treatment of atherosclerotic disease of peripheral arteries below the aortic arch and for palliation of malignant neoplasms in the biliary tree.Warning: stenting across a bifurcation could compromise future diagnostic or therapeutic procedures.¿ therefore, this is considered off label usage and as such is a violation of the ifu.Neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.
Additional Manufacturer Narrative
This device was received for analysis but the engineering report is not yet available.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: LONG GEN / PRO 29 X 90 BIL 135
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11298405
• Report Number: 9616099-2021-04247
• Device Sequence Number: 14711449
• Product Code: FGE
• UDI-Device Identifier: 20705032039809
• UDI-Public: 20705032039809
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K012590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: PG2990BPX
• Device Catalogue Number: PG2990BPX
• Device Lot Number: 82185924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 02/11/2021; 03/03/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 02/26/2021; 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .035 AQUATRACK GUIDEWIRE; 7F 90CM COOK SHUTTLE SHEATH; .035 AQUATRACK GUIDEWIRE; 7F 90CM COOK SHUTTLE SHEATH
• Patient Age: 79 YR
• Patient Weight: 70