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

Catalog Number	PXSLIMSTR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
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 thrombectomy procedure in the left arterial subclavian artery using a px slim delivery microcatheter (px slim).During the procedure, while attempting to advance the px slim through the rotating hemostasis valve (rhv) and into a non-penumbra sheath, the physician noticed the proximal end of the px slim broke into three pieces within the rhv but remained intact.The px slim was therefore removed and the procedure was completed using 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 38.0, 41.5 and 49.5 cm from the hub.Conclusions: evaluation of the returned px slim confirmed fractures on the proximal shaft.If the device is forcefully advanced against resistance or otherwise mishandled during advancement, damage such as kinks may occur.Further manipulation of a kinked device may result in fractures.No other devices associated with the complaint were returned for evaluation; therefore, the root cause of the resistance could not be determined.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.Device evaluated by mfr : placeholder.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 10/15/2019.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left arterial subclavian artery using a px slim delivery microcatheter (px slim).During the procedure, while attempting to advance the px slim through the rotating hemostasis valve (rhv) and into a non-penumbra sheath, the physician noticed the proximal end of the px slim broke in three places within the rhv but remained intact.The px slim was therefore removed and the procedure was completed using a new px slim.There was no report of an adverse effect to the patient.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8970092
• Report Number: 3005168196-2019-01709
• Device Sequence Number: 2575839
• Product Code: DQY
• UDI-Device Identifier: 00814548016443
• UDI-Public: 00814548016443
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 08/09/2019
• 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: 12/25/2021
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F87634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 10/15/2019; 12/06/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 11/11/2019; 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Date Report Sent to FDA: 01/01/2005