MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 8; QEW

Model Number	SEP8-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure for a femoropopliteal bypass using indigo system separators 8 (sep8s), an indigo system aspiration catheter 8, and non-penumbra sheath.During the procedure, the cat8 was placed through the sheath in the target vessel.While advancing the sep8 in and out of the cat8, the physician was initially able to aspirate the fresh clot quickly but suddenly noticed there was no one-to-one movement with the sep8 and cat8.Subsequently, the sep8 was removed, and upon removal, the physician noticed the tip of the sep8 had broken off inside the vessel.The cat8 was then removed, flushed, and re-advanced through the sheath to successfully aspirate and retrieve the broken tip.The physician continued the procedure and attempted to use a second sep8 with the cat8 to aspirate but the distal clot was too old and organized; therefore, the entire system was removed.Upon removal, the distal end of the cat8 appeared ¿squeezed,¿ but there was no noticeable damage to the second sep8.The physician then performed open surgery via cutdown technique to remove the distal clot.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the sep8 had a bend approximately 148.0 cm from the proximal end.The device was fractured proximal to the bulb at approximately 148.5 cm from the proximal end.The distal fractured segment was not returned for evaluation.Conclusions: evaluation of the returned sep8 confirmed a fracture on its distal tip and revealed a bend near the fracture.If the device is repeatedly manipulated against tough clot burden, the core may fatigue.Subsequently, if the device continues to be used, damage such as a fractured core wire and bulb may occur.The distal fractured segment was not returned for evaluation.Evaluation of the returned cat8 confirmed an ovalization on the distal shaft and revealed scrapes on either side of the ovalization.If the device is retracted from a parent device at an extreme angle or is otherwise forcefully pinched or gripped during use, damage such as an ovalization may occur.During functional testing, the returned sep8 was advanced through the cat8 without an issue.However, while attempting to advance a demonstration sep8 through the cat8, resistance was experienced due to a proximal ovalization and the sep8 could not advance any further.Further evaluation revealed additional ovalizations.These ovalizations were likely incidental to the reported complaint.Penumbra separators and 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.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9513539
• Report Number: 3005168196-2019-02419
• Device Sequence Number: 366336
• Product Code: QEW
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K161523
• 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): 12/04/2019
• 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: 06/05/2020
• Device Model Number: SEP8-A
• Device Catalogue Number: SEP8
• Device Lot Number: F77499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 75
• Date Report Sent to FDA: 01/01/2005