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

Model Number	400SMTXSFT0208
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using penumbra smart coils (smart coil), a non-penumbra microcatheter, a 5f non-penumbra sheath , a 4f non-penumbra angiographic catheter, and a guidewire.It was noted that the patient¿s anatomy was moderately tortuous.During the procedure, the physician successfully implanted two smart coils in the target vessel using the microcatheter.While advancing the next smart coil through the middle of the microcatheter, the physician experienced resistance.Therefore, the smart coil was retracted and removed.Subsequently, the physician flushed the microcatheter.While advancing another smart coil through the microcatheter, the smart coil became stuck at the distal tip and would not advance any further.Therefore, the smart coil was also retracted and removed.The procedure was completed using two non-penumbra coils and a non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned smart coil revealed offset coil winds on the proximal end of the embolization coil.If the smart coil is forcefully manipulated against resistance, damage such as offset coil winds may occur.The ovalization in the non-penumbra microcatheter may have contributed to resistance.Further evaluation revealed multiple kinks throughout the length of the pusher assembly and a fracture.This damage was incidental to the reported complaint.During the functional test, the embolization coil was unable to advanced out of its introducer sheath due to the offset coil winds.Evaluation of the second returned smart coil confirmed that the embolization coil was stuck inside the non-penumbra microcatheter and detached from its pusher assembly.Further evaluation revealed that the non-penumbra microcatheter distal shaft was ovalized.If the smart coil is forceful manipulated within a damage microcatheter resistance maybe encountered, and the embolization coil may detach from its pusher assembly.Further evaluation also revealed offset coil winds on the embolization coil.This damage was incidental to the reported complaint.During the functional test, the detached smart coil could not be removed from the non-penumbra microcatheter, and therefore, no functional testing could be performed.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.This report is associated with mfr report number: 3005168196-2021-02014.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12457575
• Report Number: 3005168196-2021-02013
• Device Sequence Number: 1245573
• Product Code: HCG
• UDI-Device Identifier: 00814548015552
• UDI-Public: 00814548015552
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 05/29/2024
• Device Model Number: 400SMTXSFT0208
• Device Catalogue Number: 400SMTXSFT0208
• Device Lot Number: F90683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 09/11/2021
• Supplement Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005