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

Catalog Number	PXSLIM090-B
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the px slim delivery microcatheter (px slim) was ovalized approximately 8.5 and 10.5 cm from the distal tip.The outer diameter (od) of the px slim¿s undamaged sections were measured and found to be within specification.Conclusions: evaluation of the returned device revealed that the px slim was ovalized in two locations.This type of damage likely occurs due to improper handling during use.If the device is forcefully gripped during insertion or advancement, damage such as this may occur.The ovalization in the px slim likely contributed to the resistance felt during advancement.The od of the px slim was measured and found to be within specification.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left subclavian artery using a px slim delivery microcatheter (px slim).During the procedure, the physician inserted another manufacturer's angiography catheter into the target vessel and then attempted to advance the px slim through it.However, while advancing the px slim through the angiography catheter, the physician experienced resistance and subsequently, the px slim was unable to advance any further.Therefore, the px slim was removed and the procedure was successfully completed without a microcatheter, using another manufacturer's 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: 5755340
• Report Number: 3005168196-2016-00910
• Device Sequence Number: 16279125
• Product Code: DQY
• UDI-Device Identifier: 00814548012520
• UDI-Public: 00814548012520
• 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
• Type of Report: Initial
• Report Date (Section B): 06/01/2016

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: 12/31/2017
• Device Catalogue Number: PXSLIM090-B
• Device Lot Number: F61887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2016
• Initial Report FDA Received Date: 06/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR