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

Catalog Number	PXSLIM045
Medical Device Problem Codes	Break (1069); Physical Resistance (2578); Compatibility Problem (2960)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2017
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a popliteal aneurysm using px slim delivery microcatheter (px slim).During the procedure, while attempting to advance a px slim through another manufacturer¿s catheter, the physician experienced resistance and the px slim would not advance through the catheter; therefore, it was removed.Upon removal, the physician noticed that the tip of the px slim was broken.The procedure was then completed using additional coils with no microcatheter.There was no adverse effect to the patient.
Additional Manufacturer Narrative
Results: the px slim delivery microcatheter (px slim) was fractured approximately 123.0 cm from the hub (figure 1) and ovalized from approximately 145.0 cm from the hub to the distal tip.Conclusions: evaluation of the returned device revealed it was fractured.This damage likely occurred due to forceful advancement of the px slim through a non-compatible guide catheter.The px slim instructions for use (ifu) indicate that the px slim should be used with a guide catheter of minimum inner diameter (id) of 0.053¿.If a guide catheter with an id smaller than 0.053¿ is used, resistance will likely be experienced while advancing the px slim, and the px slim may become damaged.The non-penumbra catheter mentioned in the complaint was not returned for evaluation.Penumbra 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.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6353245
• Report Number: 3005168196-2017-00237
• Device Sequence Number: 16244673
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• 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): 01/24/2017

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: Physician
• Device Expiration Date: 08/30/2019
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F71361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 03/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1