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

Catalog Number 400SMTXSFT1H04

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a coil embolization procedure using penumbra smart coils (smart coils), the physician was unable to remove the smart coil out of the packaging hoop.Therefore, the smart coil was not used in the procedure.The procedure was completed using a new smart coil.

Manufacturer Narrative

Results: the pet lock was intact at the proximal end of the pusher assembly.The pusher assembly had bends approximately 17.5 cm, 38.0 cm, 57.0 cm, 71.0 cm, 90.0 cm, 113.0 cm, 125.0 cm, 130.0 cm and 139.0 cm from the proximal end.Conclusions: evaluation of the returned smart coil revealed the device was not within a packaging hoop.The packaging hoop was not returned for evaluation; therefore, the reported inability to remove the smart coil from the packaging hoop could not be determined.Further evaluation revealed the introducer sheath was positioned incorrectly on the pusher assembly.The inner diameter (id) of the friction lock is smaller than the rest of the introducer sheath allowing the sheath to be seated properly on the pusher assembly midjoint.If the midjoint is moved proximal to the friction lock, resistance may be experienced while attempting to advance the coil distally through the introducer sheath.This could contribute to the difficulty advancing the smart coil.During functional testing, the smart coil was able to advance out of its introducer sheath and through a demonstration microcatheter.Further evaluation also revealed bends along the pusher assembly.These damages are likely incidental to the reported complaint.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 SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8129351
• MDR Text Key: 129354963
• Report Number: 3005168196-2018-02355
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015248
• UDI-Public: 00814548015248
• 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: 01/01/2005,11/05/2018

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: 12/19/2022
• Device Catalogue Number: 400SMTXSFT1H04
• Device Lot Number: F81108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• 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: 11/05/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 02/06/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1