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

Catalog Number	4002C2860
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2018
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s).It was noted that the patient's anatomy was severe tortuous and moderately calcified.During the procedure, the physician attempted to place a pc400 using a non-penumbra microcatheter, however, while advancing the pc400, the microcatheter migrated.The physician then pulled back the pc400 and made several attempts to reposition the microcatheter, but was unsuccessful; therefore, the physician removed the microcatheter with the pc400 inside.On the back table, it was noticed that the pc400 was damaged.The physician then placed a px slim delivery microcatheter and completed the procedure using new pc400s.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the proximal pet lock was intact on the proximal end of the pusher assembly.The introducer sheath was damaged on the pusher assembly.The proximal constraint sphere was intact with the distal detachment tip (ddt).The ddt was damaged.The introducer sheath was returned backwards on the pc400 assembly.The embolization coil had offset coil winds throughout the entire coil.Conclusions: evaluation of the returned pc400 revealed that the embolization coil had offset coil winds.The reported complaint mentioned that the non-penumbra microcatheter migrated from the target site while advancing the pc400 due to the tortuous patient anatomy.If the parent device migrates while attempting to advance the pc400, damage such as offset coil winds and a damaged introducer sheath may occur.Further evaluation revealed the introducer sheath was loaded onto the pc400 backwards.The friction lock inner diameter is small than the rest of the introducer sheath to ensure a proper lock with the pusher assembly mid-joint.If the pc400 is advanced through the introducer sheath friction lock, damage such as offset coil winds may occur.The offset coil winds may have contributed to the failed attempts to advance the pc400.The non-penumbra microcatheter was not returned for evaluation, therefore, the root cause of the reported complaint was unable to be determined.Penumbra coils 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: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7895008
• Report Number: 3005168196-2018-01867
• Device Sequence Number: 19181215
• Product Code: HCG
• UDI-Device Identifier: 00814548011981
• UDI-Public: 00814548011981
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 12/02/2023
• Device Catalogue Number: 4002C2860
• Device Lot Number: F66794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005