MAUDE Adverse Event Report: CORDIS CORPORATION 5MM BASKET, MEDIUM SUPPORT,; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE

Model Number 501814RMC

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.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, the membrane of 5mm basket, medium support of angioguard rapid exchange (rx) emboli capture guidewire was damaged and torn.Therefore, the device was unable to contain embolic material during the procedure.There was no reported patient injury.The device is expected to be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: the membrane of an angioguard rapid exchange (rx) 5mm basket, medium support, embolic capture guidewire (ecgw) was damaged and torn.Therefore, the device was unable to contain embolic material during the procedure.There was no reported patient injury.The product was returned for analysis.One non-sterile 5mm basket, medium support, embolic protection device along with a deployment sheath and a torque device were received for analysis inside a plastic bag.Neither original packaging nor the coil dispenser was returned.Per visual analysis, no damages could be observed on the membrane of the 5mm basket filter.Additionally, the embolic protection device was observed deployed (not loaded).Kinks were observed on the unit at 94.5 cm and at 101 cm from the distal tip.Also, an unzipped condition on the deployment sheath was observed on the delivery sheath from 26.5 cm to 37.0 cm from the delivery sheath distal end.The delivery sheath was received cut at 145 cm from the tip and an unraveled condition was observed on the soft tip of the unit.No other anomalies were observed.Per microscopic analysis, it was observed that no damages were present neither on the filter basket struts nor on the basket filter membrane.An unraveled condition was confirmed on the basket filter guidewire soft tip of the returned device.Functional analysis was not performed due to the kinked condition of the delivery sheath and the unzipped damaged condition on the embolic protection device.A product history record (phr) review of lot 35238044 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿filter basket-frayed/split/torn - in-patient ¿was not confirmed.The reported "distal tip-unraveled/stretched" was confirmed.Nonetheless, neither the cause of the reported events, nor the kinked or the unzipped condition on the unit could be conclusively determined during the analysis.Vessel characteristics (although unknown) may have contributed to the reported events.Additionally, procedural and or handling factors might have contributed to the reported events.According to the instructions for use, which is not intended as a mitigation of risk ¿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 reported events could be related to the manufacturing process of this unit.Therefore, no corrective or preventive actions will be taken at this time.

Manufacturer Narrative

H6 evaluation codes: 1664- unraveled.1601- stretched.3038 - catheter.3123 - tip.10 - testing of actual/suspected device.One non-sterile 5mm basket, medium support embolic protection device along with a deployment sheath and a torque device was received for analysis inside a plastic bag.Neither original packaging nor coil dispenser was returned for analysis.Per visual analysis of the embolic protection device received, no damages could be observed on the membrane of the 5mm basket filter.The embolic protection device was observed deployed (not loaded).Kinks were observed on the unit at 94.5 cm and at 101 cm from the distal tip.Also, an unzipped condition of the deployment sheath was observed on the delivery sheath from 26.5 cm to 37.0 cm from the delivery sheath distal end.Besides, the delivery sheath was received cut at 145 cm from the tip.Also, an unraveled condition was observed on the soft tip of unit.No other anomalies observed.Per microscopic analysis, the unit was observed under the vision system and it was observed that no damages were present neither on the filter basket struts nor on the basket filter membrane.However, unraveled condition was confirmed on the basket filter guidewire soft tip as received.Functional analysis was not performed due to the delivery sheath kinked and unzipped damaged condition on the embolic protection as received.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: 5MM 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: 9452531
• MDR Text Key: 191166169
• Report Number: 1016427-2019-03651
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 501814RMC
• Device Catalogue Number: 501814RMC
• Device Lot Number: 35238044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 12/16/2019; 01/28/2020
• Supplement Dates FDA Received: 01/10/2020; 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1