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

Model Number	400SMTHXSFT2H08
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2019
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.This report is associated with mfr report number: 3005168196-2019-02075.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right superior hypophyseal artery using a benchmark 6f 071 delivery catheter (benchmark) and penumbra smart coils (smart coils).During the procedure, while attempting to advance the benchmark in the target vessel, the physician noticed that the hub of the benchmark was cracked, and air was starting to come through the crack; therefore, the benchmark was removed.Another benchmark was then used to continue the procedure.Next, while attempting to advance a smart coil through a non-penumbra microcatheter, the smart coil would not advance into the hub of the microcatheter; therefore, it was removed.The procedure was completed using another smart coil, the second benchmark, and the same 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 the pusher assembly.The pusher assembly was kinked approximately 23.0 and 34.0 cm from its proximal end.The pusher assembly mid-joint was proximal to the introducer sheath friction lock approximately 10.5 cm.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the returned smart coil revealed offset coils winds on the embolization coil.If the introducer sheath is not aligned properly within the hub of a parent device prior to advancement, the embolization coil may take shape within the hub and damage such as offset coil winds may occur.During the functional test, resistance was experience while attempting to advance the smart coil from its returned position; therefore, the introducer sheath was removed distally, and the smart coil was re-sheathed correctly.The smart coil was then able to be advanced through its introducer sheath without an issue.While attempting to advance the smart coil through a demonstration microcatheter, resistance was encountered as the offset coil winds began to take shape inside the hub of the demonstration catheter, and smart coil could not be advanced any further.Evaluation of the returned benchmark revealed a kink underneath the strain relief.If the benchmark is manipulated at an extreme angle during use, damage such as a kink may occur.During functional testing, the benchmark was flushed with air using a syringe while submerged, and a leak was observed from underneath the strain relief.The strain relief was unraveled, and a hole was observed.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra catheters 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: 3005168196-2019-02075.

• Brand Name: PENUMBRA SMART COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9287512
• Report Number: 3005168196-2019-02074
• Device Sequence Number: 19305781
• Product Code: HCG
• UDI-Device Identifier: 00814548016016
• UDI-Public: 00814548016016
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K160832
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2019
• 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: 05/16/2022
• Device Model Number: 400SMTHXSFT2H08
• Device Catalogue Number: 400SMTHXSFT2H08
• Device Lot Number: F77169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/12/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005