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

Catalog Number 400SMTSFT0715

Device Problems Material Too Rigid or Stiff (1544); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2017

Event Type  Injury  

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: 3005168196-2018-00067, 3005168196-2018-00068, 3005168196-2018-00069, 3005168196-2018-00070, 3005168196-2018-00071.The device was implanted in the patient.

Event Description

The patient was undergoing a coil embolization procedure in the basilar artery using penumbra smart coils.During the procedure, two smart coils (f77124, c03494) were advanced and implanted using a non-penumbra microcatheter, and after being detached, the proximal ends of the coils migrated out of the aneurysm, so the smart coils were only partially within the aneurysm.Next, two other smart coils (f78441, f78758) felt gritty and were not able to be advanced into the microcatheter, and therefore the smart coils were removed.The physician then was unable to advance a smart coil (f74006) out of its introducer sheath, and therefore the smart coil was not used in the procedure.The physician was able to advance a sixth smart coil (f74006) through the rhv, but was unable to advance it into the hub of the microcatheter, and therefore the smart coil was removed.Next, the physician was unable to advance the seventh smart coil (f73219) out of its introducer sheath and into the microcatheter, and therefore the smart coil was removed.The procedure was then completed using additional smart coils.The physician also deployed two stents into the left and right posterior cerebral artery (pca) to protect the neck of the basilar artery as well as to pin down the protruding tips of the first two smart 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: 7171928
• MDR Text Key: 96624761
• Report Number: 3005168196-2018-00066
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548014722
• UDI-Public: 00814548014722
• 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: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/15/2022
• Device Catalogue Number: 400SMTSFT0715
• Device Lot Number: F77124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 78