MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 3MM30CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 48003030X

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/17/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.  the product was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.This is one of two products used during the same procedure- (b)(4).

Event Description

As reported, during an interventional endovascular procedure for treatment of a superficial femoral artery (sfa) chronic total occlusion (cto), the physician tried to remove the 150 cm.Saber 3 mm.X 30 cm.Balloon catheter (bc-complaint product #1) but the balloon snapped off.The physician then used a 150 cm.Saber 5 mm.X 30 cm.Bc (complaint product #2), but the product cracked proximal to the balloon.Parts of the saber 3 x 30 bc remained in the patient.Multiple non-cordis stents were used to secure the balloon pieces against the vessel wall.The products will be returned for inspection.Additional information received indicated that the approach for the procedure was contralateral.The target lesion was reported to be heavily calcified.Regarding the 150 cm.Saber 3 mm.X 30 cm.Bc (complaint product #1-balloon snapped off): there was no reported difficulty advancing the product to the target lesion.The balloon catheter did cross the target lesion and was inflated although the atmospheres used were not known.There was some reported withdrawal difficulty and some force was used to withdraw the product.The physician did attempt to snare the separated product but was not successful.The physician was finally able to open the target lesion and complete the procedure successfully.The patient did not experience any adverse event as a result of the reported product issue.The product was stored properly according to the instructions for use.There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu with no problems noted during preparation.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.No additional information is available.Regarding the 150 cm.Saber 5 mm.X 30 cm.Bc (complaint product #2-cracked): it was the distal tip of the product that was noted to be cracked.The product was clinically used in the patient.The reported product issue was after use and removing the product from the patient.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu with no problems noted during preparation.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.No additional information is available.

Manufacturer Narrative

During an interventional endovascular procedure for treatment of a superficial femoral artery (sfa) chronic total occlusion (cto), the physician tried to remove the 150 cm.Saber 3 mm.X 30 cm.Balloon catheter (bc-complaint product #1) but the balloon snapped off.The physician then used a 150 cm.Saber 5 mm.X 30 cm.Bc (complaint product #2), but the product cracked proximal to the balloon.Parts of the saber 3 x 30 bc remained in the patient.Multiple non-cordis stents were used to secure the balloon pieces against the vessel wall.Additional information received indicated that the approach for the procedure was contralateral.The target lesion was reported to be heavily calcified.Regarding the 150 cm.Saber 3 mm.X 30 cm.Bc (complaint product #1-balloon snapped off): there was no reported difficulty advancing the product to the target lesion.The balloon catheter did cross the target lesion and was inflated although the atmospheres used were not known.There was some reported withdrawal difficulty and some force was used to withdraw the product.The physician did attempt to snare the separated product but was not successful.The physician was finally able to open the target lesion and complete the procedure successfully.The patient did not experience any adverse event as a result of the reported product issue.The product was stored properly according to the instructions for use.There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the instructions for use (ifu) with no problems noted during preparation.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.No additional information is available.Regarding the 150 cm.Saber 5 mm.X 30 cm.Bc (complaint product #2-cracked): it was the distal tip of the product that was noted to be cracked.The reported product issue was after use and removing the product from the patient.The product was stored properly according to the ifu.There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu with no problems noted during preparation.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.No additional information is available.The products were returned for analysis.  (b)(4): one non sterile catheter of saber 3 mm x 30 cm 150 cm bc was returned.Per visual analysis no damages or separations were noted in the returned unit.Per dimensional analysis the od proximal seal was found within dimensional specification.A device history record (dhr) review of lot 17534323 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.  (b)(4): one non-sterile unit of saber 5 mm x 30 cm 150 cm bc was returned.A balloon rupture and separation was noted.The balloon separation was located at 0.5 cm from balloon proximal end.It was also noted that the inner member at the balloon section was separated.No other anomalies were noted on the device.Functional analysis was not performed due to the condition of the device.Per sem analysis the external surface revealed evidence of scratch marks adjacent to the balloon rupture and separation and it¿s very likely that the same factors that caused the scratch marks on the balloon outer surface also contributed to the ruptured and separated condition found on the returned device.The internal surface did not reveal any evidence of damages.A device history record (dhr) review of lot 17534326 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip - cracked - in-patient¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, vessel characteristics (heavy calcification) may have contributed to the burst as evidenced by scratch marks noted on the outer surface during sem analysis.The reported ¿balloon-separated - in-patient¿ and ¿pta/ptca system- withdrawal difficulty - from vessel¿ was not confirmed by analysis of the returned device as visual and dimensional analysis was performed successfully.  according to the instructions for use ¿proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.¿ neither the dhr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.  this is one of two products used during the same procedure.  please reference mfr.Report #9616099-2017-00907 and # 9616099-2017-00908.

• Brand Name: SABER 3MM30CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave.; miami lakes, FL 33014
• MDR Report Key: 6314212
• MDR Text Key: 66919480
• Report Number: 9616099-2017-00907
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 48003030X
• Device Catalogue Number: 48003030X
• Device Lot Number: 17534323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/19/2017
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention