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

Catalog Number	PXSLIM045-A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2016
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 using a px slim delivery microcatheter (px slim).During the procedure, while repositioning the px slim in the patient under fluoroscopy without experiencing any resistance, the physician noticed it was broken in the mid-shaft.The broken px slim was removed from the patient and the procedure was completed using a new px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the px slim delivery microcatheter (px slim) was fractured approximately 52.0 cm from the hub and kinked approximately 43.0 and 8.0 cm from the distal tip.Conclusion: evaluation of the returned device confirmed it was fractured and kinked.This type of damage typically occurs due to improper handling during use.If the px slim is forcefully manipulated during positioning in patient anatomy, damage such as this may occur.Px slims 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.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5745360
• Report Number: 3005168196-2016-00877
• Device Sequence Number: 18840424
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/26/2016

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: 01/31/2019
• Device Catalogue Number: PXSLIM045-A
• Device Lot Number: F67432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/26/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2016
• Supplement Report FDA Received Date: 08/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1