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

Catalog Number 400SMTHXSFT0208

Device Problems Positioning Failure (1158); Failure to Fold (1255); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2017-01894.The device was implanted into the patient.

Event Description

The patient was undergoing a coil embolization procedure in the left middle meningeal artery (mma) using penumbra smart coils.During the procedure, while attempting to place a smart coil into the target vessel using a non-penumbra microcatheter, the physician noticed that the smart coil was not taking its intended shape; therefore, it was removed and saved for later use.The physician then attempted to advance a new smart coil into the target vessel using the same microcatheter; however, the new smart coil would also not take its intended shape and was removed and save for later use.After that, the physician placed a non-penumbra coil in the target vessel using the same microcatheter.Next, the physician successfully placed the second smart coil that was previously removed.Prior to redeploying the first smart coil that was previously removed, the physician rinsed it in a saline bath to remove any blood; however, while attempting to advance the smart coil out of its introducer sheath and into the microcatheter, the physician experienced resistance at the distal end of the smart coil introducer sheath and the smart coil would not advance.Therefore, it was removed.It was also reported that resistance was encountered while attempting to advance the smart coil out of its introducer after removal from the microcatheter.The procedure was completed using a new smart coil and the same microcatheter without further issues.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SMART COIL
• 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: 6988954
• MDR Text Key: 91330927
• Report Number: 3005168196-2017-01895
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015996
• UDI-Public: 00814548015996
• 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: Physician
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 400SMTHXSFT0208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 60 YR