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

Catalog Number	PXSLIM045-A
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2016
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: 1.3005168196-2016-00194, 2.3005168196-2016-00195, 3.3005168196-2016-00196, 4.3005168196-2016-00197, 5.3005168196-2016-00198.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the a2 segment of the cerebral artery using penumbra coil 400 coils (pc400 coils), a px slim delivery microcatheter (px slim) and penumbra coil detachment handles (handle).During the procedure, while advancing a pc400 coil (lot # f63825) through the px slim, the physician met resistance and decided to remove both the px slim and the pc400 coil.After removing both devices from the patient, the physician noticed that the pc400 coil was damaged and had unintentionally detached from the pusher assembly.A new pc400 coil (lot # f63825) was then deployed into the aneurysm using a new px slim without any issues; however, the physician had difficulty detaching the pc400 coil in the aneurysm using the handle (lot # f31442).After three unsuccessful attempts to detach the pc400 coil using the handle, the physician attempted to use a new handle (lot # f31442) but was still unsuccessful.The pc400 coil was then detached manually by the physician.Another pc400 coil (lot # f36541) was then deployed into the aneurysm; however, the physician was unable to detach the coil using the handle and decided to manually detach the coil.The procedure was completed at this point since the physician considered the aneurysm to have been properly filled with the two pc400 coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
(b)(4).Results: the ps slim delivery microcatheter (px slim) was returned pinched by the packaging tray and observed to be kinked in this area.The px slim was kinked approximately 16.5 cm from the distal tip.Conclusions: evaluation of the returned devices revealed that the px slim was damaged.It is likely that the observed damage to the px slim was sustained due to the packaging tray being closed and pinched onto the device.Evaluation of the returned pc400 components revealed multiple kinks along the entire pusher assembly.The damage found on the pusher assembly was likely incidental and may have occurred during packaging for return.Further evaluation of the pc400 revealed that the sr wire was fractured, and confirmed that the embolization coil was missing.Fracture of the pc400 sr wire typically occurs due to improper handling during use.If the device is forcefully retracted against resistance, damage such as this may occur.Since the embolization coil was not returned for evaluation, no dimensional measurements could be taken.Due to the inability to perform a dimensional analysis, and the damage sustained by the pc400 pusher assembly and px slim during packaging for return, the cause of the initial resistance experienced by the physician could not be determined.Neither of the detachment handles mentioned in the initial report, nor the pc400s used with these detachment handles were returned for evaluation.Therefore, the root cause of the difficulty detaching these pc400s could not be determined.Px slims are 100% visually inspected during process inspection.Pc400s and detachment handles are 100% functionally tested during 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: 5445461
• Report Number: 3005168196-2016-00193
• Device Sequence Number: 325082
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• 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): 01/20/2016

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: 08/31/2018
• Device Catalogue Number: PXSLIM045-A
• Device Lot Number: F65255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2016
• Supplement Report FDA Received Date: 04/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR