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

Catalog Number 400SMTXSFT0308

Device Problems Bent (1059); Physical Resistance (2578); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 number: 3005168196-2017-00316.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the right middle cerebral artery (rmca) using penumbra smart coils (smart coils).During the procedure, while attempting to retract a smart coil back into the non-penumbra microcatheter for repositioning, the physician experienced resistance and subsequently, the smart coil became stretched.The physician removed the smart coil and then attempted to advance a new smart coil through the same microcatheter.While attempting to advance the new smart coil, the physician experienced slight resistance and inadvertently bent the smart coil pusher assembly.Therefore, the physician attempted to retract the coil; however, while the coil was being retracted, it became stretched at the distal end of the microcatheter.The physician was able to remove the entire coil using the pusher assembly and completed the procedure using new smart coils and the same microcatheter.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: 6393846
• MDR Text Key: 69575267
• Report Number: 3005168196-2017-00317
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015361
• UDI-Public: 00814548015361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2017

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: 11/07/2021
• Device Catalogue Number: 400SMTXSFT0308
• Device Lot Number: F72651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2016
• 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: 61 YR