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

Catalog Number 48004004X

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

As reported, there was strong resistance felt and the saber balloon catheter could not be advanced further.It was removed and found to have a kink on the distal tip.Another saber balloon was used to complete the procedure.There was no reported patient injury.After the device was received by the decontamination site, it was noted that the distal tip was near separation.The patient was a (b)(6) female.The lesion was right superficial femoral artery.The lesion was heavily calcified and not tortuous.The rate of stenosis was 99%.A contralateral approach was made from the left femoral artery with a non-cordis sheath introducer.A saber was tried to deliver to the target lesion for pre-dilatation with a non-cordis guidewire as back-up a few times, but the saber couldn't be delivered due to heavy calcification and couldn't advance further.The saber was removed from the patient and it was found that its distal tip was kinked.There was resistance felt and it couldn¿t advance.Therefore, the saber was stopped using and another saber was used instead and the procedure finished successfully.There was no reported patient injury.

Manufacturer Narrative

(continued from event description): the product was not clinically used.And it will be returned for analysis.After the device was received by the decontamination site, it was noted that the distal tip was near separation.The product 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.Concomitant devices: destination sheath, terumo; and cruise guidewire, sjm.(b)(6).

Manufacturer Narrative

Device codes: 3024- torn material.Additional information was received: there were no damages or anomalies noted to the device or packaging prior to use.It was confirmed that the distal tip was not kinked/bent or damaged prior to use.The device was stored, handled and prepped according to the ifu.There was no difficulty removing the product from the hoop or removing the protective balloon cover and stylet.No unusual force was used at any time during the procedure.The balloon catheter was easily removed from the patient and it was removed intact.The near separation of the distal tip was noted by the customer after the device was removed.There was no patient injury.Complaint conclusion: during a percutaneous transluminal angioplasty (pta) strong resistance was felt whilst trying to advance a saber 4mmxcm 150cm pta balloon dilatation catheter through a lesion.It was removed and found to have a kink on the distal tip.Another saber balloon was used to complete the procedure.There was no reported patient injury.After the device was received by the decontamination site, it was noted that the distal tip was near separation.The patient was a (b)(6) year -old female.The lesion was right superficial femoral artery.The lesion was heavily calcified and not tortuous.The rate of stenosis was 99%.A contralateral approach was made from the left femoral artery.There were no damages or anomalies noted to the device or packaging prior to use.It was confirmed that the distal tip was not kinked/bent or damaged prior to use.The device was stored, handled and prepped according to the ifu.There was no difficulty removing the product from the hoop or removing the protective balloon cover and stylet.No unusual force was used at any time during the procedure.The balloon catheter was easily removed from the patient and it was removed intact.The near separation of the distal tip was noted by the customer after the device was removed.There was no patient injury.The product was returned.One non-sterile saber 4mmx4cm 150cm was returned.Per visual analysis it was found that the distal tip of the received unit was partially separated.The device was inspected under microscope and it was noticed that the separation edges present evidence of elongations.Sem analysis was performed to the partially separated area which showed that the tip presented evidence of elongations that could be induced by an application of force on the zone of the rupture.No other anomalies were found during the analysis.Device history review (dhr) of lot 16093237 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported event of ¿distal tip - kinked/bent-in patient¿ was confirmed based on the condition of the catheter as received.As the tip of the received catheter was found bent and partially separated.As such, the complaint reported by the customer as ¿distal tip - frayed/split/ torn (peripheral)¿ was confirmed.The cause of the catheter tip kinked and damaged (partially separated) could not be conclusively determined during the analysis.Based on the information available for review, procedural factors (¿there was strong resistance felt and the saber balloon catheter could not be advanced further¿) may have contributed to the condition of the returned device.Additionally, the device was inspected by the customer prior to used and no anomalies were noted.This kink/bent and partially separated condition does not appear to be manufacturing related since sem results shows showed that the tip presented evidence of elongations that could be induced by an application of force on the zone of the rupture.The dhr and the product analysis results do not suggest that the reported issue is not related to the manufacturing process.Therefore no corrective and preventive actions will be taken at this time.

Manufacturer Narrative

(b)(6).Based on this information, there will be no changes to the conclusions reported in the 3500a-follow-up report # 1.

• Brand Name: SABER 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: 4351926
• MDR Text Key: 5204683
• Report Number: 9616099-2014-00821
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 48004004X
• Device Lot Number: 16093237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 65