MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM10CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48006010X
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product history review is expected but has not been completed.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 6mm 10cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter did not have any radiopaque markers indicating the location of the balloon.The markers noted to be missing once in the patient.A new 6x100 saber balloon was used to complete the procedure without issue.There was no reported patient injury.There was no increased length of stay associated with this event.The balloon was stored in a temp/humidity controlled environment, in the packaging/box, in procedure room.The balloon was inspected for defects prior, but not for the presence of markers.The balloon was prepped in the usual fashion per the instructions for use (ifu) and there was no difficulty removing the device from the package.There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty advancing the balloon through the sheath, over the wire, or into the patient.A 5f rain sheath was used in the anterior tibial artery.The lesion to treat was the right superficial femoral artery (sfa) which had moderate calcification.The percentage of stenosis was 100%.The device was used for a chronic total occlusion (cto).An unknown 0.14¿ stabilizer guidewire was used.The balloon wire port was flushed prior to insertion into the body.There was no difficulty crossing the lesion nor was the catheter ever in an acute bend.The balloon catheter was not kinked while being used.The contrast media being used was ge brand with a one contrast to three saline ratio.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: d4, g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, a 6mm 10cm 150 saber percutaneous transluminal angioplasty (pta) balloon catheter did not have any radiopaque markers indicating the location of the balloon.The markers noted to be missing once in the patient.A new 6x100 saber balloon was used to complete the procedure without issue.There was no reported patient injury.There was no increased length of stay associated with this event.The balloon was stored in a temp/humidity-controlled environment, in the packaging/box, in the procedure room.The balloon was inspected for defects prior, but not for the presence of markers.The balloon was prepped in the usual fashion per the instructions for use (ifu) and there was no difficulty removing the device from the package.There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty advancing the balloon through the sheath, over the wire, or into the patient.A 5f rain sheath was used in the anterior tibial artery.The lesion to treat was the right superficial femoral artery (sfa) which had moderate calcification.The percentage of stenosis was 100%.The device was used for a chronic total occlusion (cto).An unknown 0.14¿ stabilizer guidewire was used.The balloon wire port was flushed prior to insertion into the body.There was no difficulty crossing the lesion nor was the catheter ever in an acute bend.The balloon catheter was not kinked while being used.The contrast media being used was ge brand with a one contrast to three saline ratio.One product was returned for analysis.A non-sterile saber 6mm x 10cm 150 percutaneous transluminal angioplasty (pta) balloon catheter was received for analysis inside a plastic bag.Per visual analysis, no anomalies could be observed on the unit.Per microscopic analysis, the saber was inspected under the vision system and no anomalies observed.The presence of the unit¿s marker bands was verified on both the proximal and distal portions of the balloon.A product history record (phr) review of lot 82186044 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported "marker band-balloon catheters - missing component" was not confirmed by the analysis of the device.The exact cause of the reported event could not be determined.Per sem analysis the marker bands were confirmed on both the distal and proximal balloon shoulders, no anomalies were noted.Therefore, based on the information available for review, it is difficult to draw a clinical conclusion between the device and the event reported by the customer as the presence of marker bands were confirmed and no anomalies were noted on the device.According to the device description in the safety information in the instructions for use ¿the cordis saber percutaneous transluminal angioplasty (pta) dilatation catheter is a catheter with a distal inflatable balloon.Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement.For balloon lengths greater than or equal to 100mm, the distal section will have one (1) marker band and proximal section will consist of two (2) adjacent marker bands.For balloon lengths less than 100mm, the distal and proximal section will have each one (1) marker band.The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.The radiopaque marker bands (the length between the outer edge of most proximal to the outer edge of most distal marker band) indicate the stated nominal length of the balloon.¿ neither the phr review nor the product evaluation results suggest that the failure reported is related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SABER 6MM10CM 150
• Common Device Name: CATHETER, 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 Key: 16040410
• Report Number: 9616099-2022-06176
• Device Sequence Number: 12328889
• Product Code: LIT
• UDI-Device Identifier: 20705032069615
• UDI-Public: (01)20705032069615(17)230131(10)82186044
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 48006010X
• Device Catalogue Number: 48006010X
• Device Lot Number: 82186044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.14¿ UNKNOWN STABILIZER GUIDEWIRE; 5F RAIN SHEATH; 6X100 SABER BALLOON; GE BRAND CONTRAST MEDIA
• Patient Sex: Female
• Patient Weight: 147 KG