MAUDE Adverse Event Report: CORDIS CORPORATION SABER 3MM6CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 82208972 presented no issues during the manufacturing process that can be related to the reported event.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 Description

As reported, as the tip of the 3mm x 6cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) was advanced over the guidewire (unknown), the tip separated and fell.There was no reported patient injury.The device cannot be used for the patient.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The device was stored and prepped per the instructions for use (ifu).The patient had no infectious disease.The device is expected to be returned for analysis.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, as the tip of the 3mm x 6cm x 150cm saber percutaneous transluminal angioplasty (pta) balloon catheter (bc) was advanced over the guidewire (unknown), the tip separated and fell.There was no reported patient injury.The device cannot be used for the patient.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The device was stored and prepped per the instructions for use (ifu).The patient had no infectious disease.The product was returned for analysis.A non-sterile saber 3mm x 6cm 150 was received for analysis inside a plastic bag.The mentioned concomitant unknown guidewire involved in the complaint was not returned for evaluation.Per visual analysis of the saber, a piece of the tip was observed separated.The separated piece of tip was not received for evaluation.No other anomalies found.Per microscopic analysis, the unit was observed under the vision system and tip separation was confirmed.Per sem analysis the outer surface of the distal tip presented scratch marks and elongations near the separated area.This type of damage is commonly caused during the interaction of the unit material with a sharp object or mechanical damage.It is very likely that the same factors that caused the observed scratch marks and elongations on the distal tip outer surface could probably led to the separated condition on the distal tip of the unit.It seems the distal tip material was separated either due to the interaction of the unit with calcified spicules located on the lesion or with a sharp object from the outside of the unit no other issues were noted during sem analysis.A product history record (phr) review of lot 82208972 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported by the customer as ¿distal tip separated¿ was confirmed by analysis as the device was received separated and the tip was not returned.The distal tip presented evidence of elongations at the separated area during analysis of the device.However, the exact cause of the damages noted cannot be determined.The elongations and scratch marks to the outer portion of the distal tip material suggest that the unit interacted with a sharp object.The material may have been torn, then pulling and stretching events leading to a full separation caused by material tensile overload.Therefore, based on the information available procedural and handling factors likely contributed to the reported event.The distal tip was induced to stretching/pulling events that exceeded the material yield strength prior to the separation.According to the safety information in the instructions for use ¿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.If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.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 phr review nor the product analysis suggests that the found damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SABER 3MM6CM 150
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12120022
• MDR Text Key: 260041412
• Report Number: 9616099-2021-04679
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 20705032069325
• UDI-Public: 20705032069325
• Combination Product (y/n): N
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 48003006X
• Device Lot Number: 82208972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SABER BALLOON; UNKNOWN GUIDEWIRE; SABER BALLOON; UNKNOWN GUIDEWIRE