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

Catalog Number SCH1

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

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.This report is associated with mfr report numbers: 3005168196-2017-02312, 3005168196-2017-02314.

Event Description

The patient was undergoing a coil embolization procedure in the right gastro-epiploic artery using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician placed three initial non-penumbra coils into the proximal side of the parent vessel using a non-penumbra microcatheter.While attempting to advance a new smart coil out of its introducer sheath and into the microcatheter, the physician experienced resistance and the smart coil would not advance out.Therefore, the smart coil was removed and a new smart coil was opened.Next, the physician advanced the new smart coil into the target vessel and attempted to detach it using the handle but was unsuccessful.After two failed attempts, the physician opened a new handle and the smart coil was successfully detached.The procedure was then completed using five new smart coils, seven additional coils, the same microcatheter and the second handle.There was no report of adverse effect to the patient.

Manufacturer Narrative

Results: there was no visible damage to the penumbra smart coil detachment handle (handle).Conclusions: evaluation of the returned smart coil revealed that it was unable to be advanced out of its introducer sheath due to offset coil winds.If the introducer sheath is not properly aligned inside the hub, offset coil winds may result.If the embolization coil becomes damaged, resistance will likely be experienced when advancing into the parent catheter.Evaluation of the returned penumbra smart coil detachment handle (handle) revealed that it was able to exhibit sufficient pull force and throw distance.The root cause of the difficulty detaching could not be determined.Penumbra coils and handles 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 DETACHMENT HANDLE
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7154752
• MDR Text Key: 96112984
• Report Number: 3005168196-2017-02313
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016139
• UDI-Public: 00814548016139
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/04/2022
• Device Catalogue Number: SCH1
• Device Lot Number: F78027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 83 YR