MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 6 ASPIRATION CATHETER; QEW

Model Number	CAT6
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
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 thrombectomy procedure in the right common femoral artery using an indigo system aspiration catheter 6 (cat6), a non-penumbra sheath and a guidewire.It should be noted that thrombus mass had been seated inside an uncovered stent close to the tibioperoneal trunk.During the procedure, the physician used an antegrade femoral approach to place the sheath in the target location.The physician then advanced the cat6 over the guidewire proximal to the thrombus in front of the stent.Next, the physician completely removed the clot from the stent using the cat6 under continuous aspiration.Afterwards, it was then noticed that additional thrombus mass was located distal to the stent that was there due to the stent implantation that was previously not noticed.As an additional step, the physician decided to remove the additional thrombus mass that was distal to the stent.Subsequently, the physician experienced resistance while advancing the cat6 over the guidewire during the attempt to make the first pass.However, the physician continued to attempt to advance the cat6 over the guidewire.After several attempts were made, the physician was able to advance the cat6 over the guidewire through the sheath.Then, once the cat6 was advanced approximately seven to nine centimeters distal to the stent, the physician completed the pass.While attempting to remove the cat6, the physician noticed that the cat6 had become stuck in the stented vessel.Subsequently, under fluoroscopy it was noticed that there was damage to the cat6 reinforcement.It was reported that the guidewire was wrapped inside the cat6 reinforcement.While the physician continued to retract the cat6 through the stent, the distal end of the cat6 broke inside the stented vessel.However, since approximately fifteen centimeters of the distal end of the cat6 hung on the guidewire, the physician was then able slowly retract the broken cat6 into the sheath and then remove the sheath and broken cat6 together.Afterwards, a computed tomography scan (ct scan) was performed, and the physician determined that no parts of the cat6 were left inside the patient.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: (b)(4).1.Section b.Box 5.Describe event or problem evaluation of the returned cat6 confirmed a fracture on the distal shaft, and revealed internal coil winds unraveled and wrapped around the non-penumbra guidewire.Evaluation revealed that the cat6 was stretched proximal to the fractured location.This indicated that the device was stretched prior to the fracture.If the cat6 is retracted against resistance, the device may stretch and subsequently fracture.Further evaluation revealed that the distal shaft was ovalized.The root cause of this damage could not be determined; however, this damage may have contributed to resistance during removal of the cat6.Penumbra catheters 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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right common femoral artery using an indigo system aspiration catheter 6 (cat6), a non-penumbra sheath and a guidewire.It should be noted that thrombus mass had been seated inside an uncovered stent close to the tibioperoneal trunk.During the procedure, the physician used an antegrade femoral approach to place the sheath in the target location.The physician then advanced the cat6 over the guidewire proximal to the thrombus in front of the stent.Next, the physician completely removed the clot from the stent using the cat6 under continuous aspiration.Afterwards, it was noticed that additional thrombus mass was located distal to the stent due to the stent implantation.The thrombus was not previously noticed.As an additional step, the physician decided to remove the additional thrombus mass that was distal to the stent.Subsequently, the physician experienced resistance while advancing the cat6 over the guidewire during the attempt to make the first pass.However, the physician continued to attempt to advance the cat6 over the guidewire.After several attempts were made, the physician was able to advance the cat6 over the guidewire through the sheath.Then, once the cat6 was advanced approximately seven to nine centimeters distal to the stent, the physician completed the pass.While attempting to remove the cat6, the physician noticed that the cat6 had become stuck in the stented vessel.Subsequently, under fluoroscopy it was noticed that there was damage to the cat6 reinforcement.It was reported that the guidewire was wrapped inside the cat6 reinforcement.While the physician continued to retract the cat6 through the stent, the distal end of the cat6 broke inside the stented vessel.However, since approximately fifteen centimeters of the distal end of the cat6 hung on the guidewire, the physician was able to slowly retract the broken cat6 into the sheath and then remove the sheath and broken cat6 together.Afterwards, a computed tomography scan (ct scan) was performed, and the physician determined that no parts of the cat6 were left inside the patient.The procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT 6 ASPIRATION CATHETER
• Common Device Name: QEW
• 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: 14015636
• Report Number: 3005168196-2022-00151
• Device Sequence Number: 6298424
• Product Code: QEW
• UDI-Device Identifier: 00814548016245
• UDI-Public: 00814548016245
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022
• 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: 06/06/2024
• Device Model Number: CAT6
• Device Catalogue Number: CAT6
• Device Lot Number: F106872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005