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

Catalog Number	400SMTSTD0515
Medical Device Problem Codes	Difficult to Remove (1528); Retraction Problem (1536); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior choroidal artery using penumbra smart coils (smart coils).During the procedure, after advancing a smart coil in the aneurysm using a non-penumbra microcatheter, the physician determined that the smart coil was the incorrect size and decided to withdraw it; however, while attempting to withdraw the smart coil from the aneurysm, the smart coil became stuck inside the non-penumbra microcatheter.Therefore, the physician removed the microcatheter with the smart coil altogether.The procedure was completed using another smart coil and another non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of its pusher assembly.The pusher assembly was kinked approximately 29.0 thru 36.0 cm from the proximal end.The penumbra smart coil (smart coil) was advanced out of the distal tip of the non-penumbra microcatheter.The non-penumbra microcatheter was ovalized approximately 91.5 thru 101.0 cm from the hub.Conclusions: evaluation of the returned device revealed that the smart coil was stuck inside of an ovalized non-penumbra microcatheter.The ovalization in the non-penumbra microcatheter likely contributed to the reported issue.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7087585
• Report Number: 3005168196-2017-02151
• Device Sequence Number: 16594026
• Product Code: HCG
• UDI-Device Identifier: 00814548014647
• UDI-Public: 00814548014647
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2017

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
• Operator of Device: Physician
• Device Expiration Date: 10/05/2020
• Device Catalogue Number: 400SMTSTD0515
• Device Lot Number: F65960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Initial Date Received by Manufacturer: 11/08/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR