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

Catalog Number	PXSLIM090-A
Medical Device Problem Codes	Mechanical Problem (1384); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2016
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.This report is associated with mfr report numbers: 3005168196-2016-01148, 3005168196-2016-01149.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a px slim delivery microcatheter (px slim).During the procedure, while attempting to advance a ruby coil through the px slim, the physician encountered friction and subsequently, the coil was unable to advance any further.Therefore, the physician removed the ruby coil and successfully deployed and detached a new ruby coil into the target vessel using the same px slim.While advancing another new ruby coil through the same px slim, the physician did not encounter any resistance; however, after the coil was halfway deployed into the target vessel, it became stuck and unintentionally detached from its pusher assembly.The physician was then able to successfully push the detached ruby coil into the target vessel.After this, the procedure was completed using a new ruby coil and the same px slim.It should be noted that although the physician did not maintain a continuous flush and did not use a rotating hemostasis valve (rhv), a syringe flush was used before and after each coil.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 2.5 cm from the hub and ovalized approximately 3.0 cm from the distal tip.A 0.025¿ mandrel was inserted into the px slim and advanced.Resistance was experienced when the mandrel reached the fractured and ovalized segments of the px slim.Conclusion: evaluation of the returned devices revealed the px slim was fractured near the hub and ovalized near the distal tip.The fracture near the hub likely occurred due to forceful manipulation of the px slim during use.The type of ovalization near the distal tip typically occurs due to forceful gripping or otherwise compressing the px slim during insertion into a catheter.Evaluation of the ruby coil revealed the sr wire was fractured.This type of damage typically occurs due to forceful retraction of the ruby coil against resistance.The ovalization observed on the px slim likely contributed to the ruby coil becoming stuck and the subsequent unintentional detachment.The ruby coil embolization coil was not returned for evaluation.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.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5858284
• Report Number: 3005168196-2016-01147
• Device Sequence Number: 446391
• Product Code: DQY
• UDI-Device Identifier: 00814548010342
• UDI-Public: 00814548010342
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2016

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: 02/28/2019
• Device Catalogue Number: PXSLIM090-A
• Device Lot Number: F67909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2016
• Supplement Report FDA Received Date: 10/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1