MAUDE Adverse Event Report: CORDIS CORPORATION SABERX PTA DILATATION CATHETER; PTA CATHETERS (LIT)

Catalog Number 51006006L

Device Problem Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was received, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the physician felt that the marker bands for the balloon was shorter than expected.Post-dilatation was performed with the balloon on the proximal portion of the lesion.There was no reported patient injury and the device will be returned for analysis.The target lesion was right superficial femoral artery (sfa).The lesion was mildly calcified with 100% stenosis and unknown tortuosity.It is unknown if it was a chronic total occlusion.Two smart stents (6x60mm for distal portion and 7x150mm for proximal portion) were placed in the lesion.For post dilatation, a 6x60mm saber pta catheter was opened.There was no difficulty removing the product from the hoop or removing the balloon cover/stylet.There were no kinks or damages noted to the device prior to use, especially the marker bands.The device was prepped normally.It is unknown if there was resistance/friction as the device was inserted into the patient; or if there was difficulty experienced as the device was advanced to and across the lesion.It was inserted into the distal portion of the lesion.At that time, the physician felt that distance between marker bands was shorter than expected (60mm).The dilation was performed and it revealed that the position of the distal marker band did not meet the position of distal balloon shoulder approximately 10mm visually.When the balloon was inflated, the balloon was protruding out from the stent length.So the deflation was performed immediately.For the proximal portion, the position of the marker and balloon shoulder were almost same.The length of whole the balloon (shoulder to shoulder) was same as placed stent (60mm).Post-dilation in the stent where was proximal site was performed.It is unknown if the balloon inflated/deflated normally or if the device was kinked during use.It is unknown if the balloon catheter was removed easily from the patient, but the device was removed intact.It is unknown if the marker bands ever dislodged into the patient or the current status of the patient.It is unknown.The procedure finished successfully however, it is unknown if it was completed with the complaint product.There was no reported patient injury.After the procedure, the length between markers was measured.It was confirmed approximately 57mm.The length (shoulder to shoulder) was approximately 63mm when the balloon was inflated.Picture of device is not available.

Manufacturer Narrative

Complaint conclusion: the physician felt that the marker bands for the balloon were shorter than expected.Post-dilatation was performed with the balloon on the proximal portion of the lesion.There was no reported patient injury.The target lesion was right superficial femoral artery (sfa).The lesion was mildly calcified with 100% stenosis and unknown tortuosity.It is unknown if it was a chronic total occlusion.Two smart stents (6x60mm for distal portion and 7x150mm for proximal portion) were placed in the lesion.For post dilatation, a 6x60mm saber pta catheter was opened.There was no difficulty removing the product from the hoop or removing the balloon cover/stylet.There were no kinks or damages noted to the device prior to use, especially the marker bands.The device was prepped normally.It is unknown if there was resistance/friction as the device was inserted into the patient; or if there was difficulty experienced as the device was advanced to and across the lesion.It was inserted into the distal portion of the lesion.At that time, the physician felt that distance between marker bands was shorter than expected (60mm).The dilation was performed and it revealed that the position of the distal marker band did not meet the position of distal balloon shoulder approximately 10mm visually.When the balloon was inflated, the balloon was protruding out from the stent length.So the deflation was performed immediately.For the proximal portion, the position of the marker and balloon shoulder were almost same.The length of whole the balloon (shoulder to shoulder) was same as placed stent (60mm).Post-dilation in the stent where was proximal site was performed.It is unknown if the balloon inflated/deflated normally or if the device was kinked during use.It is unknown if the balloon catheter was removed easily from the patient, but the device was removed intact.It is unknown if the marker bands ever dislodged into the patient or the current status of the patient.It is unknown.The procedure finished successfully however, it is unknown if it was completed with the complaint product.There was no reported patient injury.After the procedure, the length between markers was measured.It was confirmed approximately 57mm.The length (shoulder to shoulder) was approximately 63mm when the balloon was inflated.Picture of device is not available.The device was returned for analysis.One non-sterile unit of saber 6mm x 6cm 155cm balloon catheter was returned.Per visual analysis the balloon was deflated, but appeared to have been inflated.No anomalies or damages were noted in the device.The distance between the maker bands (proximal/distal) was measured and it was found within specification.A device history record (dhr) review of lot 17310089 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon burst-at/below rbp (peripheral)¿ was not confirmed by analysis of the returned device as dimensional analysis was performed successfully.The exact cause of the reported event could not be confirmed.According to the instructions for use ¿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.Prior to angioplasty, the catheter should be examined to verify functionality and integrity, and ensure that its size and shape are suitable for the specific procedure for which it is to be used.Do not use if product damage is suspected or evident.The device performed as intended and therefore the reported event and the dhr could not be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

Manufacturer Narrative

Complaint conclusion: the physician felt that the marker bands for the balloon was shorter than expected.Post-dilatation was performed with the balloon on the proximal portion of the lesion.There was no reported patient injury.The target lesion was right superficial femoral artery (sfa).The lesion was mildly calcified with 100% stenosis and unknown tortuosity.It is unknown if it was a chronic total occlusion.Two smart stents (6x60mm for distal portion and 7x150mm for proximal portion) were placed in the lesion.For post dilatation, a 6x60mm saber pta balloon catheter (bc) was opened.There was no difficulty removing the product from the hoop or removing the balloon cover/stylet.There were no kinks or damages noted to the device prior to use, especially the marker bands.The device was prepped normally.It is unknown if there was resistance/friction as the device was inserted into the patient; or if there was difficulty experienced as the device was advanced to and across the lesion.It was inserted into the distal portion of the lesion.At that time, the physician felt that distance between marker bands was shorter than expected (60mm).The dilation was performed and it revealed that the position of the distal marker band did not meet the position of distal balloon shoulder approximately 10mm visually.When the balloon was inflated, the balloon was protruding out from the stent length.So the deflation was performed immediately.For the proximal portion, the position of the marker and balloon shoulder were almost same.The length of whole the balloon (shoulder to shoulder) was same as placed stent (60mm).Post-dilation in the stent where was proximal site was performed.It is unknown if the balloon inflated/deflated normally or if the device was kinked during use.It is unknown if the balloon catheter was removed easily from the patient, but the device was removed intact.It is unknown if the marker bands ever dislodged into the patient or the current status of the patient.It is unknown.The procedure finished successfully however, it is unknown if it was completed with the complaint product.There was no reported patient injury.After the procedure, the length between markers was measured.It was confirmed approximately 57mm.The length (shoulder to shoulder) was approximately 63mm when the balloon was inflated.The device was returned for analysis.One non-sterile unit of saber 6mm x 6cm 155cm bc was returned.Per visual analysis the balloon had been inflated and deflated.No anomalies or damages were noted in the device.The distance between maker bands (proximal/distal) and balloon length were measured (deflated and inflated) and they were found within specification.A device history record (dhr) review of lot 17310089 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿marker band - offset/out of position-in patient¿ was not confirmed by analysis of the returned device as dimensional analysis was performed successfully.The exact cause of the reported event could not be determined.According to 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.¿ the device performed as intended and therefore the reported event and the dhr could not be related to the manufacturing process; therefore, no corrective/preventive action will be taken.

• Brand Name: SABERX PTA DILATATION CATHETER
• Type of Device: PTA CATHETERS (LIT)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5521431
• MDR Text Key: 41028174
• Report Number: 9616099-2016-00150
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 51006006L
• Device Lot Number: 17310089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1