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

Catalog Number	4004C1845
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2016-00770.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400 coils (pc400 coils).During the procedure, while attempting to advance two pc400 coils through a px slim delivery microcatheter (px slim), the physician experienced resistance.Therefore, both pc400 coils were removed and the procedure was completed using new pc400 coils and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The introducer sheath was loaded backwards on the pusher assembly and the friction lock was pulled off of the introducer sheath, with damage observed on the sheath in the original friction lock location.The embolization coil was intact with the pusher assembly.Conclusion: evaluation of the first pc400 revealed the introducer sheath was loaded backwards on the pusher assembly.Further evaluation revealed the friction lock was pulled off the introducer sheath, and the introducer sheath was damaged in the original friction lock location.This damage likely occurred due to improper handling while re-loading the introducer sheath on the pusher assembly.If the introducer sheath is damaged or loaded backwards on the pusher assembly, resistance will likely be encountered upon attempting to advance the pc400 through the introducer sheath.Evaluation of the second pc400 revealed it could be advanced and retracted through its introducer sheath and a demonstration px slim without issue.Further evaluation revealed the pusher assembly was kinked near the proximal end.This damage was likely incidental and may have occurred during packaging for return.The root cause of the resistance experienced while advancing the second ruby coil could not be determined.The px slim mentioned in the complaint was not returned for evaluation.Pc400s are 100% functionally inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:(b)(4).1.Section d.Box 4.Expiration date this report is associated with mfr report number: 1.(b)(4).H3 other text : placeholder.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5717032
• Report Number: 3005168196-2016-00769
• Device Sequence Number: 511664
• Product Code: HCG
• UDI-Device Identifier: 00814548011110
• UDI-Public: 00814548011110
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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,Followup,Followup
• Report Date (Section B): 05/11/2016
• 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: 04/03/2019
• Device Catalogue Number: 4004C1845
• Device Lot Number: F20436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/11/2016
• Supplement Date Received by Manufacturer: Not provided; 01/14/2005
• Initial Report FDA Received Date: 06/10/2016
• Supplement Report FDA Received Date: 07/19/2016; 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005