MAUDE Adverse Event Report: PENUMBRA, INC. PX SLIM DELIVERY MICROCATHETER; DQY

Device Problems Kinked (1339); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-00661.

Event Description

The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed four pc400s using a px slim delivery microcatheter (px slim).The physician then felt resistance and was unable to advance another pc400 past the middle of the px slim, and therefore the physician retracted the pc400.Upon removal of the pusher assembly, the physician found that the pc400 had unintentionally detached within the px slim, and therefore the px slim was removed with the pc400 inside.It was noticed that the px slim was slightly kinked, and the procedure was therefore completed using a new microcatheter and additional coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the px slim was kinked approximately 27.5 cm from the hub and the pc400 embolization coil was inside the catheter with coagulated blood.A stainless steel mandrel was advanced through the returned px slim and encountered a strong resistance.The pc400 embolization coil was pushed out of the distal tip of the microcatheter.Subsequently, a demonstration coil was able to advance through the returned px slim and out of the distal tip with resistance.Conclusions: evaluation of the returned pc400 revealed that the pet lock was intact on the proximal end of the pusher assembly and the embolization coil was detached.If the device is forcefully retracted against resistance, the pusher assembly polymer section may elongate beyond the reach and the pull wire, and likely result in the embolization coil detaching from its pusher assembly.Evaluation of the returned px slim revealed that the catheter was kinked.If the device was bent at an extreme angle or otherwise forcefully manipulated during use, damage such as a kink may occur.This kink likely contributed to the reported resistance during the procedure and subsequent detachment of the embolization coil the od of the proximal constraint sphere and the id of the ddt were measured and found to be within specification.After using a stainless-steel mandrel to push the subject pc400 out of the catheter, a demonstration coil encountered resistance when advanced through the px slim and out of the distal tip.Penumbra coil and catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2018-00661.

Manufacturer Narrative

This report is associated with mfr report number: 3005168196-2018-00661.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7385081
• MDR Text Key: 104031271
• Report Number: 3005168196-2018-00662
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): Y
• PMA/PMN Number: K100826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,03/01/2018

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: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 08/09/2018; 01/14/2005
• Supplement Dates FDA Received: 08/15/2018; 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1