MAUDE Adverse Event Report: CORDIS CORPORATION 6MM BASKET, MEDIUM SUPPORT,; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number 601814RMC

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

A device history record (dhr) review of lot 35238004 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 6mm angioguard rx basket would not collapse when tried to capture it with the retrieval catheter.The device was never inserted into the patient.The target lesion was the internal carotid.The device was not being used to treat chronic total occlusion (cto).There was no act while the angioguard was deployed.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.The device would not retract into the delivery sheath before insertion.The angioguard was sized larger than the vessel as instructed in the ifu.The device did not pass through any acute bends.No unusual force was used at any time during the procedure.Thrombus was not present prior to, at or after the lesion site.

Manufacturer Narrative

After further review of additional information received the following sections concomitant medical products, pma/510k, if follow-up, what type, device evaluated by mfr have been updated accordingly.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections pma/510k, if follow-up, what type, device evaluated by mfr and adverse event problem have been updated accordingly.A 6mm angioguard rx basket would not collapse when tried to capture it with the retrieval catheter.The device was never inserted into the patient.The target lesion was the internal carotid.The device was not being used to treat chronic total occlusion (cto).There was no act while the angioguard was deployed.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.The device would not retract into the delivery sheath before insertion.The angioguard was sized larger than the vessel as instructed in the ifu.The device did not pass through any acute bends.No unusual force was used at any time during the procedure.Thrombus was not present prior to, at or after the lesion site.The product was returned for analysis.A non-sterile angioguard 6mm basket, medium support embolic protection device delivery sheath, a filter basket introducer, a capture sheath and a torque device were received for analysis inside a plastic bag.Neither original packaging nor coil dispenser was returned for analysis.Per visual analysis, the torque device was received affixed to the delivery wire on the proximal end of the deployment sheath beneath the green hub.The basket filter was observed overloaded into the delivery sheath.The tip of the delivery sheath was received ripped/ torn due to the overloaded condition of the basket filter into the delivery sheath.Also, uplifted basket filter membrane damages could be observed on the unit.Per microscopic analysis damages were observed on the polyurethane membrane of the filter basket.Also, compressions and distortions were observed on the nitinol struts of the basket filter unit.Functional analysis could not be performed due to the damaged condition of the angioguard delivery unit.A product history record (phr) review of lot 35238004 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿delivery system loading (docking) difficulty¿ and ¿filter basket frayed/split/torn - during loading¿ were 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, procedural and handling factors while prepping the device may have contributed to the event as evidenced by the torn delivery sheath and compressions and distortions on the nitinol struts of the basket filter unit noted during analysis.The event description wrongly described the capture sheath as the involved part in this event when it was found to be the delivery sheath.This is a commonly made descriptive mistake when reporting these events.According to the precautions in the safety information of the instructions for use, ¿guidewires are delicate instruments and should be handled carefully.Prior to use and when possible during the procedure, inspect the guidewire carefully for coil separation, bends, kinks, or damage of the filter basket assembly.The deployment and capture sheaths are delicate instruments and should be handled carefully.Prior to use, and when possible during the procedure, inspect the deployment sheath, capture sheath, and capture sheath rx port region (approximately 30 cm from the distal tip) for bends, kinks, or other damage.¿ neither the phr 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.

• Brand Name: 6MM BASKET, MEDIUM SUPPORT,
• Type of Device: TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8866342
• MDR Text Key: 154437535
• Report Number: 1016427-2019-03128
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• PMA/PMN Number: K062531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 601814RMC
• Device Catalogue Number: 601814RMC
• Device Lot Number: 35238004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1