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

Catalog Number	PXSLIM045
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the px slim was ovalized approximately 2.0 cm from the distal tip.Conclusions: evaluation of the returned device revealed the px slim was ovalized on its distal end.This damage may have occurred due to forceful manipulation of the px slim within patient anatomy.This ovalization may have contributed to the resistance experienced during the procedure.Further evaluation revealed the ruby coil was detached.Since the ruby coil was reportedly removed from the procedure with no mention of detachment, the detachment was likely incidental to the reported failure.The ruby coil could not be functionally tested for advancement through a microcatheter due to the detachment.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: 3005168196-2018-00360.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic using a ruby coil and a px slim delivery microcatheter (px slim).During the procedure, the physician successfully deployed and detached multiple ruby coils in the target location using the px slim.The physician then experienced resistance while advancing a ruby coil through the px slim, and therefore, the px slim and the ruby coil were removed.The procedure was then completed using a new px slim and a new ruby coil.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: 7277547
• Report Number: 3005168196-2018-00361
• Device Sequence Number: 11260974
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/24/2018

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
• Operator of Device: Physician
• Device Expiration Date: 12/22/2019
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F73303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1