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

Catalog Number	4004C0509
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
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 in the m1 segment of the middle cerebral artery (mca) using penumbra coils 400 (pc400).During the procedure, the physician felt resistance while advancing a pc400 within a px slim delivery microcatheter (px slim) and, consequently, the pc400 unintentionally detached within the px slim.Therefore, the physician removed the px slim with the pc400 inside.The procedure was then completed using a new microcatheter and new coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the proximal end of the pc400 embolization coil was present inside the hub of the returned px slim.The stretch resistance wire (sr wire) was fractured and the proximal constraint sphere was missing.During functional analysis, it was noted that the pc400 was detached from its pusher assembly and inside the returned px slim.The px slim had a kink in the distal shaft and bends along its length.A 0.025¿ stainless steel mandrel could not be advanced through the px slim and, therefore, the pc400 and the px slim could not be functionally tested.Conclusion: evaluation of the returned pc400 confirmed that the embolization coil was detached inside the px slim.If the pc400 is forcefully manipulated against resistance, the sr wire may become fractured.A fractured sr wire will result in the embolization coil detaching within the catheter.Further evaluation of the returned devices revealed that the px slim was kinked on its distal end and had mild bends along the length of the catheter shaft.There was no damage reported on the returned px slim.Therefore, these damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.The pc400 pusher assembly was not returned for evaluation.The root cause of the resistance while advancing the pc400 could not be determined.Penumbra coils and catheters are visually 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: 8100122
• Report Number: 3005168196-2018-02301
• Device Sequence Number: 11260457
• Product Code: HCG
• UDI-Device Identifier: 00814548010854
• UDI-Public: 00814548010854
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• 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): 10/24/2018
• 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: 07/01/2026
• Device Catalogue Number: 4004C0509
• Device Lot Number: F84455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 11/24/2018
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005