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

Catalog Number	4002C0830
Medical Device Problem Codes	Material Frayed (1262); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the carotid cleft using penumbra coil 400s (pc400s).During the procedure, while advancing a pc400 into the target vessel using a px slim delivery microcatheter (px slim), the physician visualized by fluoroscopy that the pc400 became frayed and unraveled.The pc400 was therefore removed and was no longer used in the procedure.The procedure was completed using five additional pc400s and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 11.0, 88.0, 96.0 and from 128.5 ¿ 133.0 cm from the proximal end.The pull wire was present within the pusher assembly distal detachment tip (ddt).The proximal constraint sphere was intact with the pusher assembly ddt.The embolization coil was detached from the pusher assembly.The embolization coil was stretched and unraveled.The stretch resistant(sr) wire was fractured.The introducer sheath was ovalized from approximately 46.0 ¿ 49.0 cm and from 63.0 ¿ 64.0 cm from the proximal end.Conclusions: evaluation of the returned pc400 revealed a fractured sr wire.If the device is forcefully retracted against resistance, damage such as a fractured sr wire may occur.If the sr wire fractures, the embolization coil will likely become detached from its pusher assembly.The px slim identified in the complaint was not returned for evaluation; therefore, the cause of the resistance was unable to be determined.Further evaluation revealed pusher assembly kinks and ovalizations along the introducer sheath.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8739773
• Report Number: 3005168196-2019-01235
• Device Sequence Number: 1490004
• Product Code: HCG
• UDI-Device Identifier: 00814548010564
• UDI-Public: 00814548010564
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019
• 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: 08/05/2026
• Device Catalogue Number: 4002C0830
• Device Lot Number: F85117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Date Report Sent to FDA: 01/01/2005