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

Catalog Number 400SMTSTD0930

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

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 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: 3005168196-2017-02247, 3005168196-2017-02249, 3005168196-2017-02250.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the ascending aorta using penumbra smart coils (smart coils).During the procedure, the physician successfully deployed and detached five smart coils using a non-penumbra microcatheter, but also felt resistance advancing four smart coils out of the microcatheter and into the patient.It was reported that the physician was having difficulty seeing when the smart coils exited the microcatheter, and therefore the physician was unsure whether the resistance was caused by the microcatheter positioning, a possible kink in the microcatheter, or whether the resistance was due to the smart coils.The four smart coils were therefore retracted, and the procedure was continued using shorter smart coils.The procedure was then completed using a lantern delivery microcatheter and ruby coils.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: 7131125
• MDR Text Key: 95910847
• Report Number: 3005168196-2017-02248
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548014364
• UDI-Public: 00814548014364
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/16/2022
• Device Catalogue Number: 400SMTSTD0930
• Device Lot Number: F74474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2017
• 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: 62 YR