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

Catalog Number	PXSLIMSTR-A
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 numbers: 3005168196-2016-01039, 3005168196-2016-01040.The hospital disposed of the device.
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, the physician had difficulty advancing a ruby coil through the px slim and experienced resistance.Subsequently, the coil became stuck so the physician attempted remove it.However, while the coil was being retracted, it unintentionally detached inside the px slim.The physician then removed the detached ruby coil and attempted to advance a new ruby coil through the same px slim.However, the physician still met resistance.The ruby coil became stuck and was unable to advance through the px slim.Therefore, the physician attempted to remove the ruby coil.However, while the coil was being retracted, it unintentionally detached inside the px slim.The physician removed px slim containing the detached ruby coil from the patient.Upon inspection of the px slim, a kink was observed.The technologist was unsure when the px slim became kinked.Thereafter, the procedure was completed using a new px slim and new ruby coils without any further issues.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: 5817504
• Report Number: 3005168196-2016-01038
• Device Sequence Number: 1456932
• Product Code: DQY
• UDI-Device Identifier: 00814548016436
• UDI-Public: 00814548016436
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/23/2016

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: 08/31/2016
• Device Catalogue Number: PXSLIMSTR-A
• Device Lot Number: F37878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2016
• Initial Report FDA Received Date: 07/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1