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

Catalog Number	PXSLIMSTR-A
Medical Device Problem Codes	Kinked (1339); Mechanical Problem (1384); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the px slim delivery microcatheter (px slim) was kinked approximately 5.0 cm from the distal tip.Conclusions: evaluation of the returned devices revealed the px slim was kinked in the distal shaft.This damage may have occurred due to forceful manipulation of the px slim during positioning in the patient anatomy.Further evaluation revealed the pc400 coil pusher assembly was kinked.This damage may have occurred due to forceful advancement of the pc400 coil against resistance.The kink in the px slim likely contributed to any resistance experienced during advancement of the pc400 coil.All 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.This report is associated with mfr report number: 3005168196-2016-01145.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the cerebral artery using penumbra coil 400 coils (pc400 coils) and a px slim delivery microcatheter (px slim).During the procedure, while advancing a pc400 coil through a px slim, the physician experienced resistance and was unable to advance the pc400 coil out of the px slim.The pc400 coil was re-sheathed and re-introduced into the px slim.However, the physician was still unable to advance the pc400 coil out of the px slim and the pc400 coil pusher assembly became slightly bent.Therefore, the pc400 coil and px slim were removed.The physician also reported that there may have been a kink at the distal end of the px slim.The procedure was successfully completed using a new px slim and eight new pc400 coils.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: 5858190
• Report Number: 3005168196-2016-01144
• Device Sequence Number: 16235685
• Product Code: DQY
• UDI-Device Identifier: 00814548016436
• UDI-Public: 00814548016436
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• 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: 12/31/2018
• Device Catalogue Number: PXSLIMSTR-A
• Device Lot Number: F66751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2016
• Initial Report FDA Received Date: 08/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR