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

Model Number 400SMTHXSFT2H04

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

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.

Event Description

The patient was undergoing a coil embolization procedure in the right anterior cerebral artery (aca) using penumbra smart coils (smart coils), penumbra coils 400 (pc400s), and a non-penumbra microcatheter.During the procedure, the physician placed smart coils and pc400s in the target vessel using the microcatheter.While removing the pusher assembly of the last smart coil through the rotating hemostasis valve (rhv); the tip of the pusher assembly broke; therefore, the broken tip was removed.The procedure was completed using two non-penumbra coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the returned pusher assembly was fractured and approximately 3.0 cm distal portion of the fractured pusher assembly was returned.The proximal portion of the fractured pusher was not returned.The embolization coil was detached and not returned for evaluation.Conclusions: evaluation of the returned smart coil pusher assembly confirmed a distal fracture.If the device is forcefully retracted against resistance, damage such as a pusher assembly fracture may occur.The root cause of the resistance could not be determined.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.H3 other text : placeholder.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10175365
• MDR Text Key: 195886952
• Report Number: 3005168196-2020-00799
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015750
• UDI-Public: 00814548015750
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/27/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2023
• Device Model Number: 400SMTHXSFT2H04
• Device Catalogue Number: 400SMTHXSFT2H04
• Device Lot Number: F84239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 MO