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

Catalog Number	PXSLIM090-B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the px slim delivery microcatheter (px slim) was fractured approximately 38.5 cm from the hub.Conclusions: evaluation of the returned device confirmed the complaint.The px slim was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against an angle during use, damage such as this may occur.These devices are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using a px slim delivery microcatheter (px slim).During the procedure, the physician placed a vascular plug into the main vessel of the right iia via another manufacturer's guiding sheath and then removed the vascular plug's delivery system.While the physician was advancing the px slim through the guiding sheath, the px slim became fractured approximately 15 centimeters from the hub and was removed.The physician did not experience resistance or difficulty while advancing the px slim.The procedure was completed using a new px slim and the same guiding sheath.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: 5462324
• Report Number: 3005168196-2016-00228
• Device Sequence Number: 402060
• Product Code: DQY
• UDI-Device Identifier: 00814548012520
• UDI-Public: 00814548012520
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/26/2016

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: 08/31/2018
• Device Catalogue Number: PXSLIM090-B
• Device Lot Number: F65257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2016
• Initial Report FDA Received Date: 02/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1