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

Catalog Number 400SMTHXSFT1H02

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 04/30/2019

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.(b)(4).This report is associated with mfr report number: 3005168196-2019-01087.

Event Description

The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils).During the procedure, the physician was unable to advance a smart coil out of its introducer sheath and into the hub of the non-penumbra microcatheter and, therefore, the smart coil was removed.The physician then noticed that a second smart coil was outside of its introducer sheath upon opening of the packaging.The issue with this smart coil was found prior to use and, therefore, the smart coil was not used in the procedure.The procedure was then completed using new coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the penumbra smart coil (smart coil) was returned within its introducer sheath.The pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly and had offset coil winds.Conclusions: evaluation of the returned smart coil revealed a functional and undamaged device.During functional testing, the smart coil was able to advance through its introducer sheath and a demonstration microcatheter without issue.The reported inability to advance the smart coil through its introducer sheath was unable to be confirmed.Evaluation of the second smart coil revealed a device returned inside its introducer sheath with offset coil winds.Based on the return condition, the reported complaint was unable to be confirmed and the root cause of the alleged complaint was unable to be determined.During functional testing, the device was able to advance out of its introducer sheath and a demonstration microcatheter without issue.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.Section h.Box 6.Conclusions code 1: 4316 ¿ the investigation findings do not lead to a clear conclusion about the cause of the introducer sheath being outside of its packaging upon opening.This report is associated with mfr report number: 3005168196-2019-01087.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8671210
• MDR Text Key: 147089639
• Report Number: 3005168196-2019-01088
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015651
• UDI-Public: 00814548015651
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/06/2019

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: 04/19/2023
• Device Catalogue Number: 400SMTHXSFT1H02
• Device Lot Number: F82939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• 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: 05/06/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1