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

Catalog Number	400SMTHXSFT0202
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coil).During the procedure, the physician experienced resistance and was unable to advance the smart coil within its introducer sheath and therefore, the smart coil was removed.The procedure was completed using a new smart coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly mid-joint was proximal to the introducer sheath friction lock and it was fractured approximately 139.0 cm from the proximal end.The pusher assembly had a kink at approximately 138.0 cm from the proximal end.Bends were present along the pusher assembly.The embolization coil was intact to the pusher assembly and the coil was damaged.The introducer sheath was fractured at approximately 3.0 cm from the proximal end.Conclusions: evaluation of the returned smart coil revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If the mid-joint is retracted through the friction lock, resistance will likely be experienced during advancing the device.Forceful manipulation against this resistance likely contributed to the kink and the fracture observed near the pusher assembly mid-joint.Further investigation revealed that the introducer sheath was fractured.This damage was 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
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8117318
• Report Number: 3005168196-2018-02337
• Device Sequence Number: 1516518
• Product Code: HCG
• UDI-Device Identifier: 00814548015699
• UDI-Public: 00814548015699
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/24/2022
• Device Catalogue Number: 400SMTHXSFT0202
• Device Lot Number: F78350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005