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	03/08/2019
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 internal iliac artery (iia) using a px slim delivery microcatheter (px slim).During the procedure, prior to advancement into the patient, the physician was advancing the px slim over the guidewire and noticed that the px slim was broken at the distal end.The px slim was therefore removed and was not used in the procedure.The procedure was completed using another px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the px slim was ovalized from approximately 19.0 ¿ 19.5, 22.0 - 22.5 and 79.5 ¿ 80.5 cm from the hub.The device was fractured approximately 50.0 cm from the hub.The device was kinked approximately 92.0 cm from the hub.Conclusions: evaluation of the returned px slim revealed a fracture on the mid-shaft.If the device is forcefully manipulated at extreme angles during preparation for a procedure, damage such as a fracture may occur.Further evaluation revealed ovalizations and a kink.These damages are likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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: 8557434
• Report Number: 3005168196-2019-00823
• Device Sequence Number: 2168717
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019
• 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: 08/08/2021
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F85158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005