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

Catalog Number	4004C0408
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2017
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: 3005168196-2017-01370.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed multiple coils using a px slim delivery microcatheter (px slim).The physician was then unable to detach a pc400 using a penumbra coil detachment handle (handle); therefore, the pc400 was removed.The procedure was completed using a new pc400 and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly.There was no visible damage to the penumbra coil 400 (pc400).Evaluation of the returned device revealed the pet lock was intact and the embolization coil was intact with the pusher assembly.A broken pet lock indicates that a pull force was applied to the proximal end of the pusher assembly, typically in an attempt to detach the embolization coil.If the proximal end of the pusher assembly is not properly seated in the handle prior to actuating the handle, the pet lock may not separate, and the embolization coil may not detach.During functional analysis, the pc400 was detached by a demonstration handle without issue.The handle mentioned in the complaint was not returned for evaluation.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually and functionally inspected 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: 3005168196-2017-01370.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report: 1.Describe event or problem.2.Expiration date.This report is associated with mfr report number: 3005168196-2017-01370.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s) and a penumbra coil detachment handle (handle).During the procedure, the physician successfully placed pc400s using the handle.The physician was then unable to detach a pc400 using the same handle; therefore, the pc400 was removed.The procedure was completed using a new pc400, the same handle, and the same px slim delivery microcatheter (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: 6793228
• Report Number: 3005168196-2017-01369
• Device Sequence Number: 11022546
• Product Code: HCG
• UDI-Device Identifier: 00814548010830
• UDI-Public: 00814548010830
• Combination Product (Y/N): Y
• Initial Reporter Country: NZ
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2017
• 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: Physician
• Device Expiration Date: 12/09/2020
• Device Catalogue Number: 4004C0408
• Device Lot Number: F31718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 09/26/2017; 01/14/2005
• Initial Report FDA Received Date: 08/14/2017
• Supplement Report FDA Received Date: 09/26/2017; 03/26/2019
• 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