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

Catalog Number	DH1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the nose cone was removed from the handle body and it was noticed to be damaged.A 0.020¿ pin gauge was able to advance through the damaged nose cone.The handle body was undamaged.The handle body was opened and all components within the handle were undamaged.Conclusions: evaluation of the returned handle revealed the nose cone was damaged.The nose cone was measured and was found to be out of specification.If a device is forcefully advanced into the handle, damage such as this may occur.During functional testing, while attempting to detach a demonstration coil using the handle, the proximal end of the pusher assembly became stuck within the handle.Evaluation of the returned pc400 revealed a fractured pusher assembly.If the device is forcefully mishandled while retracting the device from its packaging hoop, damage such as a kink may occur.If a kinked device is further manipulated, damage such as a fracture may occur.Penumbra handles are 100% visually inspected and functionally tested during incoming quality inspection.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.This report is associated with mfr report number: 3005168196-2019-01346.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s) and a penumbra coil detachment handle (handle).The physician detached a pc400 using the handle, however, the physician then found that the proximal end of the pusher assembly was stuck in the handle.The procedure was completed using additional pc400s and the same handle.There was no report of an adverse effect to the patient.While preparing another pc400 for the procedure, the hospital staff found that it was kinked within its packaging.The damage to this pc400 was found prior to use and therefore, it was not used in the procedure.The procedure was completed using a new pc400.

• Brand Name: PENUMBRA COIL 400 DETACHMENT HANDLE
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8984700
• Report Number: 3005168196-2019-01704
• Device Sequence Number: 3275509
• Product Code: HCG
• UDI-Device Identifier: 00814548011974
• UDI-Public: 00814548011974
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: K120330
• 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
• Report Date (Section B): 08/12/2019
• 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: 11/29/2021
• Device Catalogue Number: DH1
• Device Lot Number: F87267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 09/10/2019
• 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