MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 5; DXE

Model Number	SEP5-A
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2020
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 numbers: 3005168196-2020-01409, 3005168196-2020-01411, 3005168196-2020-01412.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the peroneal artery and anterior tibial artery using indigo system cat5 aspiration catheters (cat5s), indigo system separators 5 (sep5s), a non-penumbra sheath and a guidewire.During the procedure, the physician advanced a cat5 over the guidewire through the sheath and into the left peroneal artery antegrade.The sep5 was then advanced and the physician worked his way down using the sep5 and there was slow but constant flow most of the time.Two passes were completed using the cat5 and sep5.The physician then came to a curve in the target artery and the lumen of the vessel seemed significant narrower and experienced resistance while advancing and retracting the sep5 out of the tip of the cat5.Subsequently, no progress was observed with the thrombus aspiration; therefore, the physician decided to remove the sep5 and cat5.Upon removal, it was noticed that one fifth of the distal end of the cat5 was ovalized and the sep5 was kinked at multiple points.It was reported that the sep5 was pulled through its introducer sheath on the table to see if the sep5 would go through or straighten; however, the sep5 broke inside the introducer sheath outside of the patient.Next, the physician continued the procedure using an indigo system cat3 aspiration catheter (cat3) without any separator in the more distal and narrowed part of the peroneal artery.After successfully completing the aspiration in that part of the peroneal artery, the physician advanced a new cat5 with a new sep5 into the anterior tibial artery.It was reported that the thrombus seemed much more organized and the physician had to work a lot with the sep5 to get some clot out.After some time without progress with the thrombus aspiration, the physician removed the sep5 and noticed that the wire distal to the sep5 bulb was missing.It was then observed that the wire of the sep5 was still in the anterior tibial artery and aspiration with the cat5 was unsuccessful.Therefore, the cat5 was removed.Upon removal, it was noticed that the cat5 was ovalized at the distal end.The physician then placed a non-penumbra aspiration catheter and advanced a micro guidewire through the catheter.The micro guidewire had several tiny loops and the physician was able to catch and successfully remove the broken wire of the sep5.Afterwards, the physician proceeded with the aspiration using the same catheter but was unable to advance down the anterior tibial artery as intended.The procedure ended at this point.It was reported that no improvement of the perfusion was observed in the area of the patient¿s toes.There was no report of an adverse effect to the patient related to any of the penumbra devices.
Additional Manufacturer Narrative
Results: the first returned sep5 pusher wire was kinked approximately 50.0, 52.0, 149.0 and 174.0 cm form the proximal end.The core wire was fractured proximal to the bulb and wrapping wire was unraveled approximately 175.0 cm from the proximal end.The core wire was also fractured distal to the bulb.Conclusions: evaluation of the first returned cat5 confirmed that the distal shaft was ovalized.If the device is advanced into a narrowed anatomy resistance may be experienced.If the device is advanced into the narrowed vessel against this resistance, the distal region of the catheter may become damaged.The ovalization likely contributed to the difficulty aspirating and manipulating the sep5 reported during the procedure.Functional testing confirmed difficulty advancing a sep5 through the damaged regions of the catheter.Further evaluation of the device revealed kinks on the catheter.This damage was likely incidental to the complaint.Evaluation of the first returned sep5 confirmed that the pusher wire was kinked.The cat5 ovalization may have contributed to difficulty manipulating the sep5.Repeated manipulation of the sep5 through the damaged region of the catheter would likely cause the tip to become damaged.Further evaluation revealed the sep5 was also fractured on the distal tip.This was likely due to the reported attempt to retract the damaged separator into the introducer sheath outside of the body.Evaluation of the second returned sep5 confirmed that the atraumatic tip distal to the bulb was fractured.The cat5 ovalization may have contributed to difficulty manipulating the sep5.Repeated manipulation of the sep5 through the damaged region of the catheter would likely cause the tip to become damaged.Further evaluation of the device revealed kinks on the pusher wire.This damage was likely incidental to the complaint.Evaluation of the second returned cat5 confirmed that the distal shaft was ovalized.If the device is repeatedly manipulated in difficulty clot burden the distal tip may become damaged.Functional testing confirmed difficulty advancing a sep5 through the damaged regions of the catheter.Penumbra catheters and separators are 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 numbers: 1.3005168196-2020-01409, 2.3005168196-2020-01411, 3.3005168196-2020-01412.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the peroneal artery and anterior tibial artery using indigo system cat5 aspiration catheters (cat5s), indigo system separators 5 (sep5s), a non-penumbra sheath and a guidewire.During the procedure, the physician advanced a cat5 over the guidewire through the sheath and into the left peroneal artery antegrade.The sep5 was then advanced and the physician worked his way down using the sep5 and there was slow but constant flow most of the time.Two passes were completed using the cat5 and sep5.The physician then came to a curve in the target artery and the lumen of the vessel seemed significant narrower and experienced resistance while advancing and retracting the sep5 out of the tip of the cat5.Subsequently, no progress was observed with the thrombus aspiration; therefore, the physician decided to remove the sep5 and cat5.Upon removal, it was noticed that one fifth of the distal end of the cat5 was ovalized and the sep5 was kinked at multiple points.It was reported that the sep5 was pulled through its introducer sheath on the table to see if the sep5 would go through or straighten; however, the sep5 broke inside the introducer sheath outside of the patient.Next, the physician continued the procedure using an indigo system cat3 aspiration catheter (cat3) without any separator in the more distal and narrowed part of the peroneal artery.After successfully completing the aspiration in that part of the peroneal artery, the physician advanced a new cat5 with a new sep5 into the anterior tibial artery.It was reported that the thrombus seemed much more organized and the physician had to work a lot with the sep5 to get some clot out.After some time without progress with the thrombus aspiration, the physician removed the sep5 and noticed that the wire distal to the sep5 bulb was missing.It was then observed that the wire of the sep5 was still in the anterior tibial artery and aspiration with the cat5 was unsuccessful.Therefore, the cat5 was removed.Upon removal, it was noticed that the cat5 was ovalized at the distal end.The physician then placed a non-penumbra aspiration catheter and advanced a micro guidewire through the catheter.The micro guidewire had several tiny loops and the physician was able to catch and successfully remove the broken wire of the sep5.Afterwards, the physician proceeded with the aspiration using the same catheter but was unable to advance down the anterior tibial artery as intended.The procedure ended at this point and no improvement of the perfusion was observed in the area of the patient¿s toes.It was also reported that the patient expired the following day due to an unrelated other cause.Additionally, the patient was seriously ill and had a sepsis.There was no report of an adverse effect to the patient related to any of the penumbra devices.

• Brand Name: INDIGO SYSTEM SEPARATOR 5
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10508491
• Report Number: 3005168196-2020-01410
• Device Sequence Number: 3033710
• Product Code: DXE
• UDI-Device Identifier: 00814548016108
• UDI-Public: 00814548016108
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K160533
• 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): 08/14/2020
• 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: 08/22/2022
• Device Model Number: SEP5-A
• Device Catalogue Number: SEP5
• Device Lot Number: F92677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/14/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 50
• Date Report Sent to FDA: 01/01/2005