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

Catalog Number	PXSLIMSTR-A
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Physical Resistance (2578); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2016-00507.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a coronary fistula using ruby coils and a px slim delivery microcatheter (px slim).During the procedure, the physician used several other manufacturers'' guidewires to position the px slim in the target vessel.While attempting to deliver a ruby coil, the physician experienced resistance and the ruby coil was unable to advance through the px slim.The physician removed the ruby coil and then tried to advance another manufacturer's coil through the px slim but met resistance again and removed the other manufacturer's coil.The physician then made a second attempt to advance the previous ruby coil through the px slim and this time around, the ruby coil advanced through the px slim but encountered a lot of resistance.After advancing 1-2 centimeters, the ruby coil became stuck in the px slim and could not be advanced or retracted.Therefore, the physician retracted the px slim and then removed the ruby coil from the px slim.The px slim was then removed and inspected for kinks.The physician did not observe any kinks but noticed that the last 3 centimeters of the px slim distal tip was rough.The procedure was successfully completed using another manufacturer's coils and another manufacturer's microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the px slim delivery microcatheter (px slim) was delaminated approximately 2.5 and 3.5 cm from the distal tip.Conclusion: evaluation of the returned devices revealed that the distal shaft of the px slim was partially delaminated.The multiple attempts to access the target vessel with multiple guide wires likely caused the inner lumen of the px slim to become fatigued.A fatigued px slim lumen may create kink points in the distal shaft, which will cause the delaminated section of the catheter to collapse during advancement through the patient anatomy.Further evaluation of the returned devices revealed that the ruby coil pusher assembly was kinked.This damage likely occurred due to attempting to advance the ruby coil through a kinked or collapsed px slim lumen.The ruby coil was functionally tested by penumbra investigators using a new px slim.The ruby coil was introduced through the hub of the new px slim and advanced out the distal tip without an issue.Ruby coils are 100% visually and functionally evaluated during in-process inspection.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: 5596171
• Report Number: 3005168196-2016-00506
• Device Sequence Number: 230228
• Product Code: DQY
• UDI-Device Identifier: 00814548016436
• UDI-Public: 00814548016436
• 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): 03/22/2016

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: 10/31/2018
• Device Catalogue Number: PXSLIMSTR-A
• Device Lot Number: F65946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2016
• Supplement Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 95