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

Catalog Number	PXSLIMSTR
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2017
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 number: 3005168196-2017-00462.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the brachiocephalic artery using a px slim delivery microcatheter (px slim).During the procedure, the physician placed another manufacturer¿s catheter in the target vessel and attempted to advance a px slim through it; however, resistance was encountered and subsequently, the px slim became kinked at the mid-shaft.Therefore, it was removed.The physician then attempted to advance a new px slim through the catheter; however resistance was encountered again and the px slim became kinked at the mid-shaft.Therefore, it was removed.The procedure was completed using another manufacture¿s microcatheter, the same catheter and additional coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the px slim was kinked approximately 129.5 cm from the hub on the first px slim evaluated.The outer diameter (od) of both px slim were measured and found to be within specification.Conclusions: evaluation of the both returned px slims were confirmed to be kinked.This type of damage likely occurred due to forceful advancing the device against resistance.The od of both px slim were measured and found to be within specification.The root cause of the reported resistance could not be determined.Penumbra catheters are visually 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: 3005168196-2017-00462.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6439380
• Report Number: 3005168196-2017-00461
• Device Sequence Number: 783427
• Product Code: DQY
• UDI-Device Identifier: 00814548016443
• UDI-Public: 00814548016443
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2017

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: 12/02/2018
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F66752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1