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

Model Number	DH1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
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: 3005168196-2020-00268.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using a ruby coil, a penumbra coil 400 detachment handle (handle) and a velocity delivery microcatheter (velocity).During the procedure, the physician was unable to detach the ruby coil using the handle after several attempts.Therefore, the physician used a hemostat forceps to pull the pusher assembly and detach the coil.The procedure was completed at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative on 16-apr-2020 indicated that the device was misplaced by the hospital and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.Based on this information, corrections were made to: section d.Box 10.Device available for evaluation? (do not send to fda); section h.Box 3.Reason for non-evaluation; section h.Box 3.''other'' reason for non-evaluation.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: 3005168196-2020-00268.
Additional Manufacturer Narrative
Please note that the device in complaint was not expected to be returned; however, on 27-apr-2020 the device was received.Based on this information, corrections were made to: 1.Section d.Box 10: device available for evaluation? (do not send to fda) 2.Section h.Box 3: device returned to manufacturer)? 3.Section h.Box 3: device evaluated by manufacturer? 4.Section h.Box 6: method code 1, method code 2, and method code 3 5.Section h.Box 6: results code 1 additional information was added to: 1.Section d.Box 10: returned to manufacturer on (mm/dd/yyyy) results: the handle was undamaged.Conclusions: evaluation of the returned handle revealed an undamaged, functional device.During functional testing, the handle was tested using a handle test fixture and performed within specification.Subsequently, the handle was used to detach a demonstration ruby coil without an issue.The reported complaint could not be confirmed.The root cause of the detachment issue could not be determined.Penumbra handles are 100% visually inspected and functionally tested during incoming quality inspection.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: 1.3005168196-2020-00268 h3 other text : placeholder.

• 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: 9767841
• Report Number: 3005168196-2020-00267
• Device Sequence Number: 11485590
• Product Code: HCG
• UDI-Device Identifier: 00814548011974
• UDI-Public: 00814548011974
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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,Followup,Followup
• Report Date (Section B): 02/07/2020
• 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: 09/30/2022
• Device Model Number: DH1
• Device Catalogue Number: DH1
• Device Lot Number: F93409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 04/16/2020; 05/22/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/20/2020; 06/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005