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

Model Number	PXSLIM045-B
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2020
Type of Reportable Event	Malfunction
Additional 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: 3005168196-2020-00871.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s), a px slim delivery microcatheter (px slim) and a non-penumbra catheter.During the procedure, the physician placed a pc400 in the target vessel using the px slim.While advancing the next pc400 through the px slim, the pc400 became stuck; therefore, the physician decided to remove it.While retracting the pc400, the px slim broke approximately 30 centimeters from its hub.It was reported that the rest of the px slim remained within the non-penumbra catheter.Therefore, the physician pulled the catheter with the broken px slim together.The procedure was completed using a new pc400 and a new px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the px slim was fractured approximately 56.0 cm from the hub.The distal segment of the fractured px slim was within the non-penumbra catheter.The non-penumbra catheter was undamaged.Coagulated blood was within the distal tip of the non-penumbra catheter, and the distal tip of the px slim was proximal to the coagulated blood.The px slim distal fractured segment was unable to be removed from the non-penumbra catheter.Conclusions: evaluation of the returned pc400 revealed a detached embolization coil due to a fractured sr wire.If the device is retracted against resistance damage such as this may occur.Further evaluation revealed that the pusher assembly was knotted.This damage was likely incidental to the complaint.Evaluation of the returned px slim revealed a fracture at the mid-shaft, and the distal fractured segment was within the non-penumbra catheter and was unable to be removed.If the device was manipulated against resistance, damage such as a kink and subsequent fracture may occur.Evaluation of the non-penumbra catheter revealed coagulated blood within the distal tip.This damage may have contributed to resistance during the procedure.Penumbra coils and catheters are 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: 1.3005168196-2020-00871 h3 other text : placeholder.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10222630
• Report Number: 3005168196-2020-00872
• Device Sequence Number: 536097
• Product Code: DQY
• UDI-Device Identifier: 00814548016412
• UDI-Public: 00814548016412
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: PXSLIM045-B
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F91721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 09/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005