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

Catalog Number 400SMTHXSFT2H06

Device Problems Failure to Advance (2524); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pet material was shifted proximal from its initial position, less than 0.5 cm from the proximal end of the penumbra smart coil (smart coil) introducer sheath.An imprint of the pet material¿s original position was observed 3.0 cm from the proximal end of the introducer sheath.Conclusions: evaluation of the returned smart coil revealed that the pet lock was shifted proximal from its initial position on the introducer sheath.The tightened region of the introducer sheath from the pet material¿s original position was visible and felt when tracking the pusher mid-joint through that region.The pet lock may have shifted as a result of tightly gripping while advancing against a resistance.During functional analysis, the smart coil was advanced through a demonstration microcatheter without issue.Therefore, the root cause of the reported failure could not be determined.Evaluation of the returned penumbra smart coil detachment handle (handle) revealed that it was within specification.The returned handle was tested on the test fixture in the lab and performed within specification.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are functionally tested during incoming inspection by quality.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure to treat a basilar tip aneurysm using penumbra smart coils (smart coils).During the procedure, the physician placed fourteen non-penumbra coils into the target aneurysm using a non-penumbra microcatheter.The physician then attempted to advance a new smart coil out of its introducer sheath and into the microcatheter; however, the coil was unable to advance out and appeared to be stuck.Therefore, the introducer sheath containing the smart coil was removed and the procedure was completed using seven additional 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: 7317853
• MDR Text Key: 101855926
• Report Number: 3005168196-2018-00500
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548015767
• UDI-Public: 00814548015767
• 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
• Report Date: 02/05/2018

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: 06/22/2022
• Device Catalogue Number: 400SMTHXSFT2H06
• Device Lot Number: F77859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• 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
• Patient Weight: 43