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

Catalog Number SCH1

Device Problems Mechanical Problem (1384); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2017

Event Type  malfunction  

Manufacturer Narrative

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: 3005168196-2018-00214, 3005168196-2018-00215.

Event Description

The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) to the inferior mesenteric artery (ima) to treat a type ii endoleak using penumbra smart coils (smart coils) and a penumbra smart coil detachment handle (handle).During the procedure, the physician deployed and detached two smart coils into the target vessel using a non-penumbra microcatheter and the handle.The physician then advanced a new smart coil into the target vessel and attempted to detach it using the same handle; however, the smart coil would not detach.After five attempts, the smart coil finally detached.The physician then advanced another smart coil into the target vessel and attempted to detach it using the same handle but the coil did not detach.After several attempts, the smart coil would still not detach.The physician then partially pulled back the lever of the handle and manually held it in order to adjust the force; however, the smart coil did not detach.Therefore, the physician used forceps to manually detach the smart coil.Thereafter, the procedure was completed using a new handle and additional smart coils.There was no report of an 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 handle revealed that it was able to generate sufficient pull force and throw distance during functional testing.If the smart coil pull wire is not fully inserted into the handle nose cone, difficulty detaching may be experienced.Penumbra 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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7217363
• MDR Text Key: 98414130
• Report Number: 3005168196-2018-00213
• 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: 12/27/2017

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: Physician
• Device Expiration Date: 09/19/2022
• Device Catalogue Number: SCH1
• Device Lot Number: F79586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 01/24/2018
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2017
• 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: 74 YR