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

Catalog Number	PXSLIM045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	09/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery using penumbra coil 400s (pc400) and px slim delivery microcatheters (px slim).During the procedure, the pc400 unintentionally detached as it was being retracted into the 45 degree px slim to be repositioned, and migrated to the middle cerebral artery.The 45 degree px slim was removed.The physician attempted to retrieve the detached pc400 using another manufacturer's stent retriever through another manufacturer's microcatheter; however, the pc400 broke into two pieces and only part of the coil was retrieved.The second part was removed on another pass with the stent retriever, opening the blocked vessel.Subsequently, the physician used a new px slim straight and implanted two pc400 coils.The physician then noticed on the angiography image that the aneurysm was bleeding, and reported that the px slim caused the rupture by touching the aneurysm dome.The physician then implanted two additional pc400 coils; the bleeding stopped, and the procedure was then completed.
Additional Manufacturer Narrative
Result: the px slim delivery microcatheter (px slim) was slightly bent in the distal shaft.A 0.025¿ mandrel was inserted into the px slim and advanced out of the distal tip without issue.Conclusion: evaluation of the returned devices revealed the penumbra coil 400 (pc400) embolization coil was detached from the pusher assembly and had a fractured sr wire.Fracture of the sr wire typically occurs due to forceful retraction of the pc400 against resistance.If the sr wire becomes fractured, it will allow the embolization coil to detach.Further evaluation revealed the pc400 pusher assembly was bent.This damage was likely incidental and may have occurred during packaging for return.Evaluation of the px slim revealed it was slightly bent in the distal shaft.These bends may have occurred due to forceful manipulation of the px slim during positioning within patient anatomy.The bends in the distal shaft did not cause resistance when advancing a 0.025¿ mandrel through the px slim.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.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6038519
• Report Number: 3005168196-2016-01485
• Device Sequence Number: 912392
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K100826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F68342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2016
• Supplement Report FDA Received Date: 12/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR