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

Catalog Number	PXSLIM045-A
Medical Device Problem Codes	Mechanical Problem (1384); Physical Resistance (2578); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2016
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 attempting to insert a ruby coil into the px slim, the physician experienced resistance and the coil was unable to be inserted.Therefore, the px slim was removed and the procedure was successfully completed using a new px slim and the same ruby coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the px slim delivery microcatheter (px slim) was kinked approximately 11.0 cm from the distal tip.Conclusion: evaluation of the returned device revealed that the distal shaft of the px slim was kinked.This type of damage likely occurred due to improper handling during use.If the device is forcefully advanced at an angle during insertion, damage such as this may occur.Further evaluation of the ruby coil revealed that this device was not associated with the reported issue, since the ruby coil mentioned in the complaint was successfully implanted in the patient.Multiple attempts were made to determine why this device was returned for evaluation.As of december 08, 2016 no response has been received as to why this device was returned.This investigation is based on the px slim reported issue.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: 5668061
• Report Number: 3005168196-2016-00691
• Device Sequence Number: 16256383
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/21/2016

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: 06/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2016
• Supplement Report FDA Received Date: 12/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR