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

Catalog Number	PXSLIM090-B
Medical Device Problem Codes	Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the hub was cut off the proximal end of the px slim.The distal tip of the px slim was ovalized.Conclusions: evaluation of the returned devices revealed the pc400 embolization coil was detached from the pusher assembly with the proximal constraint sphere intact.This damage likely occurred due to improper handling during use.If excessive force is used during retraction it is likely that the polymer portion of the pc400 coil will elongate, effectively extending the distal detachment tip (ddt) distal to the reach of the pull wire distal end.This will allow the proximal constraint sphere of the embolization coil to become detached from the pusher assembly.Evaluation of the returned px slim revealed the distal tip of the px slim was ovalized.This damage may have occurred due to forceful manipulation of the px slim during positioning within patient anatomy, and may have contributed to resistance during attempts to retract the pc400 coil into the px slim.Evaluation of both returned penumbra devices revealed their proximal ends were fractured off.This damage likely occurred during attempts to retrieve the detached embolization coil from the patient anatomy, as described in the complaint.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: 3005168196-2016-01114.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra coil 400 coils (pc400 coils) and a px slim delivery microcatheter (px slim).During the procedure, the physician deployed a pc400 coil into the aneurysm; however, the coil migrated to the middle cerebral artery (mca).The tip of the px slim was still in the aneurysm but it was difficult to remove the pc400 coil from the mca so the physician decided to reposition the px slim outside of the aneurysm in order to reduce resistance and deflection.The physician then attempted to retract the pc400 coil pusher assembly back through the px slim; however, the pc400 coil unintentionally detached.Therefore, the physician cut off the hub of the px slim and required a snare device to remove the detached pc400 coil from the patient.The procedure was then completed using another manufacturers'' coils and microcatheter.It should be noted that the physician used a rotating hemostasis valve (rhv) and maintained a continuous flush of saline during the procedure.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: 5847315
• Report Number: 3005168196-2016-01115
• Device Sequence Number: 13663640
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2016

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: 07/31/2018
• Device Catalogue Number: PXSLIM090-B
• Device Lot Number: F64871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2016
• Initial Report FDA Received Date: 08/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR