MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4004C1135
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 coil (pc400 coil) pusher assembly; the coil was compressed distally, kinked, and intact with the pusher assembly.Conclusions: evaluation of the returned device revealed that the pc400 coil was compressed distally inside the introducer sheath.This type of damage typically occurs due to improper handling during use.If the device is forcefully manipulated against resistance, damage such as this may occur.The px slim mentioned in the complaint was not returned for evaluation.These devices are 100% functionally tested during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400 coils (pc400 coils).During the procedure, the physician deployed and detached a pc400 coil into the aneurysm using a px slim delivery microcatheter (px slim).While attempting to deliver a new pc400 coil, the physician was unable to advance the coil into the px slim and removed the coil.The procedure was completed using a new pc400 coil and the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5426989
• Report Number: 3005168196-2016-00145
• Device Sequence Number: 13595174
• Product Code: HCG
• UDI-Device Identifier: 00814548010991
• UDI-Public: 00814548010991
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2016

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: 08/16/2023
• Device Catalogue Number: 4004C1135
• Device Lot Number: F65360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2016
• Initial Report FDA Received Date: 02/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR