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

Catalog Number 400SMTXSFT3H06

Device Problems Separation Failure (2547); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2019

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 using penumbra smart coils (smart coil).During the procedure, it was reported that the smart coil would not deploy.No additional information is available.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up # 01 mfr report.Section h.Box 6.Device code 1.Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked at approximately 15.0 cm, 32.0 cm and 35.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds.The introducer sheath was not returned for evaluation.The outer diameter of the pusher assembly was measured and was within specification.Conclusions: the evaluation of the first returned smart coil revealed pusher assembly kinks and offset coil winds along the embolization coil.This damage typically occurrs due to forceful manipulation or mishandling of the device.The reported allegation is unclear; therefore, the root cause of the issue experienced was unable to be determined.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.Section h.Box 6.Device code 1:3191 - appropriate code is not available to describe deployment issue.Section h.Box 6.Conclusions code 1:4316 - the investigation findings do not lead to a clear conclusion about the root cause of deployment issue.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG,KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9008839
• MDR Text Key: 157812192
• Report Number: 3005168196-2019-01747
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548017112
• UDI-Public: 00814548017112
• 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: 01/01/2005,08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2023
• Device Catalogue Number: 400SMTXSFT3H06
• Device Lot Number: F85391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• 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: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1