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

Model Number 4004C0815-A

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2020

Event Type  malfunction  

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: 3005168196-2020-00536.

Event Description

The patient was undergoing a coil embolization procedure in the vein of galen using penumbra coils 400 (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the physician placed four pc400s in the vein using the px slim.While advancing the next pc400, the physician experienced resistance, and the friction lock on the introducer sheath broke; therefore, the pc400 was removed.It is unknown if the pc400 entered the px slim.The physician continued the procedure and placed another pc400 in the vein.While advancing the next pc400 through the px slim, the pc400 broke; subsequently, the physician removed part of the pc400 with the pusher assembly attached.The rest of the pc400 that was still inside the px slim was pushed into the vein.The procedure was complete with other pc400s, non-penumbra coils, and the same px slim.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of its pusher assembly.The pusher assembly was kinked approximately 5.0 cm from its proximal end.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the first returned pc400 was unable to confirm the resistance experienced.Further evaluation revealed a proximal kink.This damage was not reported; therefore, is likely incidental to the reported event.The returned pc400 was able to be advanced through a demonstration microcatheter up to the kink without an issue.The reported event was unable to be confirmed.Evaluation of the second pc400 returned revealed an undamaged, functional device with the embolization coil intact with the pusher assembly.The reported event of a detached coil was not confirmed.This indicates the wrong device was returned for evaluation.Penumbra coils 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.This report is associated with mfr report number: 3005168196-2020-00536 h3 other text : placeholder.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #2 mfr report: (b)(4).1.Section b.Box 5.Describe event or problem this report is associated with mfr report number: 3005168196-2020-00536 h3 other text : placeholder.

Event Description

The patient was undergoing a coil embolization procedure in the vein of galen using penumbra coils 400 (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, the physician placed four pc400s in the vein using the px slim.While advancing the next pc400, the physician experienced resistance while advancing coil.Therefore, the pc400 was removed.The physician continued the procedure and placed another pc400 in the vein.While advancing the next pc400 through the px slim, the coil unintentionally detached.Subsequently, the physician removed the pusher assembly with part of the coil still attached.The rest of the coil that remained in the px slim was pushed into the vein.The procedure was complete with other pc400s, non-penumbra coils, and the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9941315
• MDR Text Key: 187951427
• Report Number: 3005168196-2020-00535
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018522
• UDI-Public: 00814548018522
• Combination Product (y/n): Y
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4004C0815-A
• Device Catalogue Number: 4004C0815
• Device Lot Number: F90467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 4 DA