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

Model Number 400SMTXSFT0206

Device Problems Failure to Advance (2524); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2020-01154, 3005168196-2020-01155.

Event Description

The patient was undergoing a coil embolization procedure using a px slim delivery microcatheter (px slim) and penumbra smart coils (smart coils).During the procedure, it was reported that the px slim and two smart coils were "defective".No additional information has been provided.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a coil embolization procedure using penumbra smart coils (smart coils) and a px slim delivery microcatheter (px slim).During the procedure, it was reported that two smart coils would not advance out of their introducer sheaths and a px slim was ¿defective¿.No additional information has been provided.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 08/17/2020: section b.Box 5.Describe event or problem; section h.Box 6.Device code 1.This report is associated with mfr report numbers: 3005168196-2020-01154; 3005168196-2020-01155.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of its pusher assembly.The pusher assembly was kinked approximately 8.0 and 58.5 cm from its proximal end.The embolization coil was intact with its pusher assembly and had offset coil winds.A hardened substance was observed inside the introducer sheath.During functional analysis, the smart coil could not be re-sheathed due to harden substance inside the introducer sheath, and therefore, the smart coil could not be functionally tested.Conclusions: evaluation of the returned lantern revealed an undamaged, functional device.During the functional test, a stainless-steel mandrel was advanced through the returned lantern without an issue.Evaluation of the first returned smart coil revealed offset coil winds on the embolization coil.Further evaluation revealed that the pusher assembly mid-joint was proximal to the introducer sheath friction lock and the pusher assembly was kinked.If the smart coil is advanced against resistance, damage such as offset coil winds may occur.Subsequently, if the pusher assembly mid-joint is retracted proximal to the introducer sheath friction lock, resistance may be encountered upon advancement, and the smart coil may not advance within its introducer sheath.If the device is forcefully advanced against this resistance, damage such as a kink in the pusher assembly may result.During the functional test, resistance was encountered while attempting to advance the smart coil from its returned position.Therefore, the smart coil was retracted from its pusher assembly and attempted to be re-sheathed properly; however, resistance was encountered due to a kink in the pusher assembly, and the smart coil could not be functionally tested.Evaluation of the second returned smart coil revealed that the reported complaint could not be confirmed.The smart coil was returned with the introducer sheath off the pusher assembly.Further evaluation revealed kinks in the pusher assembly and offset coil winds.This damage was likely incidental to the reported complaint.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra catheters 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.This report is associated with mfr report numbers: 1.3005168196-2020-01154, 2.3005168196-2020-01155.

• Brand Name: PENUMBRA SMART COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10382946
• MDR Text Key: 202165630
• Report Number: 3005168196-2020-01156
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016030
• UDI-Public: 00814548016030
• 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,Followup
• Report Date: 01/01/2005,07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400SMTXSFT0206
• Device Catalogue Number: 400SMTXSFT0206
• Device Lot Number: F95907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• 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: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1