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

Catalog Number	PXSLIM045
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2016-01448.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400''s (pc400''s) and a px slim delivery microcatheter (px slim).During the procedure, the physician decided to retract the pc400 due to incorrect sizing; however, upon retraction, the pc400 became stuck in the px slim.The physician then removed the px slim to remove the stuck pc400 and noticed that the tip of the px slim had an accordion-like compression damage.Therefore, the procedure was completed using a new px slim and additional pc400s.It should be noted that the physician used a rotating hemostasis valve (rhv) and maintained a continuous flush during the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the px slim delivery microcatheter (px slim) was kinked and ovalized in multiple locations throughout its length.Conclusions: evaluation of the returned devices revealed that the px slim was kinked and ovalized in multiple locations throughout its length.This damage may have occurred due to forceful manipulation of the px slim during advancement or positioning within patient anatomy.The damage observed on the px slim likely contributed to the pc400 becoming stuck inside the px slim during the procedure.Further evaluation revealed that the pc400 could be advanced through a demonstration px slim without an issue.The pc400 pusher assembly was bent in multiple locations.This damage may have occurred due to forceful manipulation of the pc400 after it became stuck in 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: 6019356
• Report Number: 3005168196-2016-01449
• Device Sequence Number: 1917572
• Product Code: DQY
• UDI-Device Identifier: 00814548016405
• UDI-Public: 00814548016405
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 09/12/2016

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: 11/30/2018
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F66492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2016
• Supplement Report FDA Received Date: 12/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR