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

Model Number SCH1

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

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: 3005168196-2019-02287; 3005168196-2019-02288; 3005168196-2019-02289; 3005168196-2019-02290.

Event Description

The patient was undergoing a coil embolization procedure in the gastric varices using penumbra smart coils (smart coils) and a penumbra smart coil (handle).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician placed and detached the first three smart coils in the target vessel after making multiple attempts in detaching the coils using the handle.While attempting to place fourth smart coil, the physician made multiple attempts to detach it using the handle; however, the smart coil failed to detach.Therefore, the handle was removed.The physician then completed the procedure using a new handle to detach the same fourth smart coil.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the device in complaint was expected to be returned; however, additional information received from the distributor indicated that the device was discarded and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.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: 1.3005168196-2019-02287 2.3005168196-2019-02288 3.3005168196-2019-02289 4.3005168196-2019-02290.

• Brand Name: PENUMBRA SMART COIL DETACHMENT HANDLE
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9453843
• MDR Text Key: 170456666
• Report Number: 3005168196-2019-02286
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548016139
• UDI-Public: 00814548016139
• Combination Product (y/n): Y
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCH1
• Device Catalogue Number: SCH1
• Device Lot Number: F90396
• Was Device Available for Evaluation?: No
• 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: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR